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Lupin Pharmaceuticals

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uuid0006o5g

Namestring
Lupin Pharmaceuticals
Legal namestring
Lupin Pharmaceuticals, Inc.
Company typeenum
Private
Founded yearint
1968
Descriptiontext

Lupin Pharmaceuticals, Inc. (LPI) is the U.S. commercial subsidiary of Lupin Ltd, the Indian multinational pharmaceutical company founded in 1968 by Dr. Desh Bandhu Gupta. Headquartered in Naples, Florida, LPI commercializes a diversified pharmaceutical portfolio spanning generics, complex generics, inhalation medications, branded products, and specialty medicines, serving healthcare providers and patients across 100+ countries. The company is a major pharmaceutical player by prescriptions in the U.S. and operates through country-specific brand entities in Canada, the UK, Germany, Australia, Brazil, Mexico, South Africa, the Philippines, Switzerland, and the Netherlands.

The company's underlying technology platform centers on advanced pharmaceutical manufacturing, including a proprietary long-acting injectable platform branded PrecisionSphere™, from which Lupin launched Risperidone Long-Acting Injectable with 180-day Competitive Generic Therapy exclusivity in the U.S. in November 2025. Additional capability is being built in peptide ingredient production and contract development and manufacturing services (CDMO) through an expansion of the Dabhasa, India facility, targeting the global advanced therapeutics and peptide market. The company also offers generics and complex generics across multiple therapeutic areas and an innovative medicines portfolio addressing unmet medical needs.

Lupin's revenue model is built on traditional pharmaceutical distribution: products move through wholesale distributors, pharmacy networks, healthcare institutions, and institutional buyers in the U.S. and global markets. Pricing is not publicly disclosed at the product level. Recent significant cash outflows include a $90 million settlement with Astellas over Mirabegron patent litigation and a $30 million antitrust settlement with Humana as part of the consolidated In Re Generic Pharmaceuticals Antitrust Litigation. Marketing channels are primarily LinkedIn and the corporate news/media section, with no public pricing or digital channel data disclosed.

Short descriptiontext

Lupin Pharmaceuticals, Inc. is the U.S. commercial subsidiary of Indian parent Lupin Ltd, commercializing generics, complex generics, inhalation, branded, and specialty medicines across 100+ countries via its proprietary PrecisionSphere™ injectable platform and traditional pharmaceutical distribution channels.

Operating statusenum
Operating
Ownership categoryenum
Headcount rangeband
501–1,000
akta.pro rankint
HeadquartersBaltimore, United States
HQ citystring
Baltimore
HQ countrystring
United States
HQ regionstring
North America
Markets served

Serves global market

Keyword5 values
generic pharmaceuticals, complex generic drugs, pharmaceutical manufacturing, specialty medications, inhalation drug delivery
Industry3 codes
1Small-Molecule Generics (Branded/Unbranded)
CodeHLAIABAAPrimaryYes
2Specialty Care Pharmaceuticals
CodeHLAIAAABPrimaryNo
3Neurology & CNS Specialty Pharmaceuticals
CodeHLAIACACPrimaryNo
NAICS code2 codes
  • Pharmaceutical Preparation Manufacturing325412
  • Drugs and Druggists' Sundries Merchant Wholesalers424210
SIC code2 codes
  • Pharmaceutical Preparations2834
  • Wholesale-Drugs, Proprietaries & Druggists' Sundries5122
Product category
Generic Pharmaceuticals
Social media profiles1 record
Marketing channels2 records

Each record includes

Title, Type, Stage, Description, Source

Distribution channels1 record

Each record includes

Title, Type, Scope, Target buyer, Description, Source

Cost components6 values
Supply Chain, Operations, Technology or R&D, Personnel, Infrastructure, Marketing or Sales
GTM typeB2B
B2B
Offering typeHardware or Manufacturing
Hardware or Manufacturing
Core offering1 text field

Lupin Pharmaceuticals is a global pharmaceutical company that develops, manufactures, and commercializes generic, complex generic, inhalation, branded, and specialty pharmaceutical products for the U.S. and international markets. The company also operates proprietary drug delivery platforms such as PrecisionSphere™ for long-acting injectables and provides contract development and manufacturing (CDMO) services for peptides and advanced therapeutics.

Differentiator
Functional benefit
Problem solved
Product overview1 text field

Lupin Pharmaceuticals is a global pharmaceutical company offering a diversified portfolio of generic medicines, complex generics, innovative medicines, and specialty medications. The company operates its proprietary PrecisionSphere™ long-acting injectable platform for extended-release formulations. Product offerings include generics and complex generics targeting various therapeutic areas, innovative branded medications, and contract development manufacturing (CDMO) services for peptides and advanced therapeutics through its expanded Dabhasa facility in India.

Product and service5 records
1Risperidone Long-Acting Injectable
CategoryGeneric Pharmaceuticals
Description

A long-acting injectable formulation of risperidone, used in the treatment of psychiatric conditions such as schizophrenia and bipolar disorder, offered to U.S. healthcare providers and patients with 180-day competitive generic therapy exclusivity.

2Generics and Complex Generics
CategoryGeneric Pharmaceuticals
Description

Lupin's core portfolio of generic pharmaceutical products, including complex generics that provide cost-effective alternatives to brand-name medications across a broad range of therapeutic areas, targeting patients and healthcare providers globally.

3Innovative Medicines (Branded and Specialty)
CategorySpecialty Pharmaceuticals
Description

Specialty and branded pharmaceutical products focused on addressing unmet medical needs through novel therapeutic approaches, including inhalation medications, for healthcare providers and patients.

4Mirabegron Generic
CategoryGeneric Pharmaceuticals
Description

Generic version of Astellas' Myrbetriq (mirabegron), a medication used for the treatment of overactive bladder, offered as a cost-effective alternative to the brand-name product for U.S. patients and healthcare providers.

5Peptide CDMO Services
CategoryContract Manufacturing Services
Description

Contract development and manufacturing services for peptides and advanced therapeutics, supported by Lupin's expanded Dabhasa facility in India with peptide ingredient production capacity, offered to pharmaceutical and biotechnology clients in the global peptide market.

Recent move6 records

Each record includes

Date, Type, Title, Description, Source

Expansion highlight5 records

Each record includes

Type, Description

Peers10 records
TypeDirect peer
Description

Largest generic pharmaceutical manufacturer globally with a deep US generics portfolio. Directly comparable to Lupin in oral solids, complex generics, and specialty categories, with overlapping therapeutic areas.

TypeDirect peer
Description

Pure-play global generics and biosimilars leader spun out of Novartis. Directly competes with Lupin in US retail generics and complex generics, with similar customer bases (pharmacies, wholesalers, hospitals).

TypeDirect peer
Description

Major US-headquartered generics and specialty pharma company formed via Mylan-Upjohn merger. Direct competitor in generic and complex generics across the same channels as Lupin.

TypeDirect peer
Description

Canadian-based generic pharmaceutical manufacturer with significant US market presence. Directly comparable to Lupin in oral solid generics, complex generics, and injectable product lines.

TypeDirect peer
Description

India-based global generic pharmaceutical company with a substantial US subsidiary (Aurobindo Pharma USA). Closely comparable Indian-headquartered peer with overlapping US generics portfolio and similar scale.

TypeDirect peer
Description

India's largest pharmaceutical company and major US generics player via Sun Pharma Global FZE. Directly comparable Indian peer with similar specialty-generics mix and US distribution footprint.

TypeDirect peer
Description

Indian multinational generic and specialty pharmaceutical company with strong US operations. Directly comparable to Lupin in injectable generics, biosimilars, and branded specialty categories.

TypeDirect peer
Description

Jordan-headquartered specialty and generic pharmaceutical company with major US operations (Hikma Pharmaceuticals USA). Comparable to Lupin in injectables, generics, and specialty branded products.

TypeDirect peer
Description

Indian multinational pharmaceutical company with US generics operations. Comparable Indian-headquartered peer with similar strategic focus on complex generics and specialty products in the US market.

TypeBroad incumbent
Description

US-focused specialty pharmaceutical company with generics and branded specialty franchises. Overlaps with Lupin's specialty generics portfolio and serves similar physician/payer customers in the US market.

Market position
Strengths4 records

Each record includes

Headline, Details, Source

Weaknesses4 records

Each record includes

Headline, Details, Source

Competitive moat5 records

Each record includes

Type, Details

Key risks5 records

Each record includes

Headline, Details, Source

Key highlights6 records

Each record includes

Headline, Details, Source

Customer concentration

Classification, Details

Segment1 record

Each record includes

Title, Type, Primary, Description, Pain point addressed, Use case, Source

Ideal customer profile1 record

Each record includes

Profile, Firmographic size, Sales motion, Sales cycle length, Buying structure, Purchase trigger, Buyer persona, Geography, Industry vertical, Primary use case, Description, Pain points, Evidence proof points, Target buyer

Technology focused
No
API detail
Has APIbool
No

Docs URL, Description

AI maturity
App detail

Has app

Feature2 records

Each record includes

Title, Differentiator, Description, Source

Core technology
Revenue estimate
Valuation estimate
Number of profiles
Subsidiaries1 record

Each record includes

Name, Acquired on, Relationship type, Type, Business focus

No data
Funding overview

Funding stage, Last funding date, Total funding USD

Funding rounds

Each record includes

Round, Amount USD, Date, Pre money valuation, Total investors, Investors, News

Investors

Each record includes

Name, Type, Date of entry, Rounds participated, Website

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Each record includes

Name, Acquisition type, Announced date, Completed date, Status, Website, News

Investment

Each record includes

Name, Round, Announced date, Lead investor, Website, News

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Lupin Pharmaceuticals

Generic Pharmaceuticalslupinpharmaceuticals.com

Lupin Pharmaceuticals, Inc. is the U.S. commercial subsidiary of Indian parent Lupin Ltd, commercializing generics, complex generics, inhalation, branded, and specialty medicines across 100+ countries via its proprietary PrecisionSphere™ injectable platform and traditional pharmaceutical distribution channels.

What Lupin Pharmaceuticals does

Lupin Pharmaceuticals, Inc. (LPI) is the U.S. commercial subsidiary of Lupin Ltd, the Indian multinational pharmaceutical company founded in 1968 by Dr. Desh Bandhu Gupta. Headquartered in Naples, Florida, LPI commercializes a diversified pharmaceutical portfolio spanning generics, complex generics, inhalation medications, branded products, and specialty medicines, serving healthcare providers and patients across 100+ countries. The company is a major pharmaceutical player by prescriptions in the U.S. and operates through country-specific brand entities in Canada, the UK, Germany, Australia, Brazil, Mexico, South Africa, the Philippines, Switzerland, and the Netherlands.

The company's underlying technology platform centers on advanced pharmaceutical manufacturing, including a proprietary long-acting injectable platform branded PrecisionSphere™, from which Lupin launched Risperidone Long-Acting Injectable with 180-day Competitive Generic Therapy exclusivity in the U.S. in November 2025. Additional capability is being built in peptide ingredient production and contract development and manufacturing services (CDMO) through an expansion of the Dabhasa, India facility, targeting the global advanced therapeutics and peptide market. The company also offers generics and complex generics across multiple therapeutic areas and an innovative medicines portfolio addressing unmet medical needs.

Lupin's revenue model is built on traditional pharmaceutical distribution: products move through wholesale distributors, pharmacy networks, healthcare institutions, and institutional buyers in the U.S. and global markets. Pricing is not publicly disclosed at the product level. Recent significant cash outflows include a $90 million settlement with Astellas over Mirabegron patent litigation and a $30 million antitrust settlement with Humana as part of the consolidated In Re Generic Pharmaceuticals Antitrust Litigation. Marketing channels are primarily LinkedIn and the corporate news/media section, with no public pricing or digital channel data disclosed.

Lupin Pharmaceuticals firmographics

Firmographics
Name
Lupin Pharmaceuticals
Legal name
Lupin Pharmaceuticals, Inc.
Website
https://lupinpharmaceuticals.com
Company type
Private
Founded year
1968
Operating status
Operating
Headcount range
501–1,000 employees
Short description
Lupin Pharmaceuticals, Inc. is the U.S. commercial subsidiary of Indian parent Lupin Ltd, commercializing generics, complex generics, inhalation, branded, and specialty medicines across 100+ countries via its proprietary PrecisionSphere™ injectable platform and traditional pharmaceutical distribution channels.
Ownership category
akta.pro rank

Lupin Pharmaceuticals industry classification

Industry
Product category
Generic Pharmaceuticals
NAICS
Pharmaceutical Preparation Manufacturing (325412), Drugs and Druggists' Sundries Merchant Wholesalers (424210)
SIC
Pharmaceutical Preparations (2834), Wholesale-Drugs, Proprietaries & Druggists' Sundries (5122)
akta.pro primary industry
Small-Molecule Generics (Branded/Unbranded) (HLAIABAA)
akta.pro secondary industries
Specialty Care Pharmaceuticals (HLAIAAAB), Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

Keywords

  • Generic pharmaceuticals
  • Complex generic drugs
  • Pharmaceutical manufacturing
  • Specialty medications
  • Inhalation drug delivery

Where Lupin Pharmaceuticals is headquartered

Location

Headquarters

HQ city
Baltimore
HQ country
United States
HQ region
North America

Markets served

Lupin Pharmaceuticals business model

Business model
GTM type
B2B
Offering type
Hardware or Manufacturing
Cost components
Supply Chain, Operations, Technology or R&D, Personnel, Infrastructure, Marketing or Sales

Distribution channels1 record

Marketing channels2 records

Lupin Pharmaceuticals product offering

Product offering

Core offering

Lupin Pharmaceuticals is a global pharmaceutical company that develops, manufactures, and commercializes generic, complex generic, inhalation, branded, and specialty pharmaceutical products for the U.S. and international markets. The company also operates proprietary drug delivery platforms such as PrecisionSphere™ for long-acting injectables and provides contract development and manufacturing (CDMO) services for peptides and advanced therapeutics.

Product overview

Lupin Pharmaceuticals is a global pharmaceutical company offering a diversified portfolio of generic medicines, complex generics, innovative medicines, and specialty medications. The company operates its proprietary PrecisionSphere™ long-acting injectable platform for extended-release formulations. Product offerings include generics and complex generics targeting various therapeutic areas, innovative branded medications, and contract development manufacturing (CDMO) services for peptides and advanced therapeutics through its expanded Dabhasa facility in India.

Differentiator

Problem solved

Functional benefit

Products and services

  • Risperidone Long-Acting Injectable A long-acting injectable formulation of risperidone, used in the treatment of psychiatric conditions such as schizophrenia and bipolar disorder, offered to U.S. healthcare providers and patients with 180-day competitive generic therapy exclusivity.
  • Generics and Complex Generics Lupin's core portfolio of generic pharmaceutical products, including complex generics that provide cost-effective alternatives to brand-name medications across a broad range of therapeutic areas, targeting patients and healthcare providers globally.
  • Innovative Medicines (Branded and Specialty) Specialty and branded pharmaceutical products focused on addressing unmet medical needs through novel therapeutic approaches, including inhalation medications, for healthcare providers and patients.
  • Mirabegron Generic Generic version of Astellas' Myrbetriq (mirabegron), a medication used for the treatment of overactive bladder, offered as a cost-effective alternative to the brand-name product for U.S. patients and healthcare providers.
  • Peptide CDMO Services Contract development and manufacturing services for peptides and advanced therapeutics, supported by Lupin's expanded Dabhasa facility in India with peptide ingredient production capacity, offered to pharmaceutical and biotechnology clients in the global peptide market.

Companies that use Lupin Pharmaceuticals

Customer profile

Segments1 record

Ideal customer profiles1 record

Lupin Pharmaceuticals technology and API

Technology

Technology focussed No

API detail

Has API
No
API docs
API detail

Core technology

AI maturity

App detail

Feature2 records

Lupin Pharmaceuticals partnerships and signals

Strategic signal

Recent moves6 records

Expansion highlights5 records

Lupin Pharmaceuticals competitors and assessment

Company assessment

Direct peers

  • Teva Pharmaceutical Industries: Largest generic pharmaceutical manufacturer globally with a deep US generics portfolio. Directly comparable to Lupin in oral solids, complex generics, and specialty categories, with overlapping therapeutic areas.
  • Sandoz (Novartis): Pure-play global generics and biosimilars leader spun out of Novartis. Directly competes with Lupin in US retail generics and complex generics, with similar customer bases (pharmacies, wholesalers, hospitals).
  • Viatris: Major US-headquartered generics and specialty pharma company formed via Mylan-Upjohn merger. Direct competitor in generic and complex generics across the same channels as Lupin.
  • Apotex: Canadian-based generic pharmaceutical manufacturer with significant US market presence. Directly comparable to Lupin in oral solid generics, complex generics, and injectable product lines.
  • Aurobindo Pharma: India-based global generic pharmaceutical company with a substantial US subsidiary (Aurobindo Pharma USA). Closely comparable Indian-headquartered peer with overlapping US generics portfolio and similar scale.
  • Sun Pharmaceutical Industries: India's largest pharmaceutical company and major US generics player via Sun Pharma Global FZE. Directly comparable Indian peer with similar specialty-generics mix and US distribution footprint.
  • Dr. Reddy's Laboratories: Indian multinational generic and specialty pharmaceutical company with strong US operations. Directly comparable to Lupin in injectable generics, biosimilars, and branded specialty categories.
  • Hikma Pharmaceuticals: Jordan-headquartered specialty and generic pharmaceutical company with major US operations (Hikma Pharmaceuticals USA). Comparable to Lupin in injectables, generics, and specialty branded products.
  • Zydus Lifesciences: Indian multinational pharmaceutical company with US generics operations. Comparable Indian-headquartered peer with similar strategic focus on complex generics and specialty products in the US market.

Broad incumbents

  • Endo International: US-focused specialty pharmaceutical company with generics and branded specialty franchises. Overlaps with Lupin's specialty generics portfolio and serves similar physician/payer customers in the US market.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat5 records

Key risks5 records

Key highlights6 records

Customer concentration

Lupin Pharmaceuticals social profiles

Digital presence

Lupin Pharmaceuticals financial estimates

Financial estimate

Revenue estimate

Valuation estimate

Lupin Pharmaceuticals leadership team

Management profile

Number of profiles

Lupin Pharmaceuticals subsidiaries and ownership

Company hierarchy

Subsidiaries1 record

Lupin Pharmaceuticals funding detail

Funding detail

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

Lupin Pharmaceuticals M&A and investment

M&A and investment

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Lupin Pharmaceuticals

What does Lupin Pharmaceuticals do?

Lupin Pharmaceuticals is a global pharmaceutical company that develops, manufactures, and commercializes generic, complex generic, inhalation, branded, and specialty pharmaceutical products for the U.S. and international markets. The company also operates proprietary drug delivery platforms such as PrecisionSphere™ for long-acting injectables and provides contract development and manufacturing (CDMO) services for peptides and advanced therapeutics.

Is Lupin Pharmaceuticals a public or private company?

Lupin Pharmaceuticals is a private company. It is classified as corporate owned and is currently operating.

When was Lupin Pharmaceuticals founded?

Lupin Pharmaceuticals was founded in 1968. It employs 501 to 1,000 people.

Where is Lupin Pharmaceuticals based?

Lupin Pharmaceuticals is headquartered in Baltimore, United States, in the North America region.

Who are Lupin Pharmaceuticals's main competitors?

Direct peers on record are Teva Pharmaceutical Industries, Sandoz (Novartis), Viatris, Apotex, Aurobindo Pharma, Sun Pharmaceutical Industries, Dr. Reddy's Laboratories, Hikma Pharmaceuticals and Zydus Lifesciences. Endo International is listed as a broad incumbent.

Does Lupin Pharmaceuticals have an API?

No public API is recorded for Lupin Pharmaceuticals.

What industry is Lupin Pharmaceuticals in?

Lupin Pharmaceuticals's product category is Generic Pharmaceuticals. Its primary akta.pro industry code is HLAIABAA, Small-Molecule Generics (Branded/Unbranded), with a secondary code of HLAIAAAB, Specialty Care Pharmaceuticals. Its NAICS code is 325412 and its SIC code is 2834.

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Live signals
The Cool DownMore than 2 million eye drops recalled in the US, but patients shouldn't stop use abruptlyMore than 2.5 million bottles of prednisolone acetate ophthalmic suspension 1%, a prescription steroid eye drop, have been voluntarily recalled by Lupin Pharmaceuticals Inc. after concerns about possible foreign material in the product. The FDA classified the recall as Class II on June 30, its second-highest risk category, noting that serious health effects are not expected but temporary or reversible problems can still occur. Patients are being advised not to stop using the medication abruptly and instead to consult healthcare providers for guidance on replacement prescriptions or tapering plans.Mirage News2.5 Million Bottles Of Prescription Eye Drops RecalledLupin Pharmaceuticals has voluntarily recalled more than 2.5 million bottles of prednisolone acetate ophthalmic suspension, USP, 1% prescription eye drops due to potential foreign substance contamination. The recall affects multiple lots across 5 mL, 10 mL, and 15 mL bottle sizes, with expiration dates ranging from July 2026 through February 2028, and the affected product was manufactured by Lupin Limited in India. No adverse events related to this recall have been reported, and the company states the voluntary recall demonstrates its quality-control system is functioning properly.HealthMore Than 2 Million Bottles of Eye Drops Recalled Over Potential ContaminationLupin Pharmaceuticals Inc. has recalled more than 2.5 million bottles of prednisolone acetate eye drops due to possible foreign substance contamination. The FDA issued a Class II recall classification on June 30, indicating the products are unlikely to cause serious health effects but may cause temporary or reversible consequences. Pharmacists are advising affected patients to consult their healthcare provider before making any changes to their medication routine.FiercePharmaLupin recalls more than 2.5M prescription eye drop bottles, citing possible contaminationLupin Pharmaceuticals issued a voluntary recall of more than 2.5 million bottles of prednisolone acetate ophthalmic suspension (prescription steroid eye drops) on June 4 after discovering an undisclosed contaminant. The recall has been designated as a Class II event by the FDA, meaning the product is defective but not inherently life-threatening, with no adverse effects reported as of last week. The affected eye drops were manufactured at Lupin's Pithampur, India facility and distributed nationwide in the United States in 5-, 10-, and 15-ml doses.The Seattle TimesMillions of eye drop bottles recalled over contamination concernsOver 2 million bottles of prednisolone acetate ophthalmic suspension eye drops were voluntarily recalled this month after the discovery of a foreign substance that may have compromised medication safety. The recalled steroid eye drops, manufactured in India by Lupin Pharmaceuticals, prompted the FDA to warn consumers to compare lot numbers with its recall notice, though the agency stated the risk of severe injury was "remote" with no reported injuries as of Friday. The recall is part of a pattern of eye drop and ointment recalls in recent years, including one in 2023 linked to four deaths, with experts citing concerns about reduced FDA oversight of foreign drug manufacturers.Business StandardUS recalls 2.5 mn bottles of India-made eye drops after contamination scareLupin Pharmaceuticals Inc. voluntarily recalled 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension eye drops in the United States after the FDA identified a possible contamination issue, specifically the potential presence of a foreign substance. The recall, classified as a Class II by the FDA, applies to products that may cause temporary or medically reversible adverse health consequences; the affected medicine was manufactured by Lupin Limited at its facility in Pithampur, Madhya Pradesh, India. Patients using the prescription eye drops, commonly used to treat redness, itching, and swelling caused by eye infections, have been advised to check whether their bottles belong to the affected lots.AInvestThe Sterile Bottles That Weren'tLupin Pharmaceuticals voluntarily recalled 2,530,182 bottles of prednisolone acetate ophthalmic suspension, a steroid eye drop labeled "Sterile" that the FDA found to contain foreign particulate matter. The FDA classified the recall as Class II on June 30, suggesting temporary or medically reversible harm risk, with the affected product representing an estimated $198 million annual US market. The incident raises questions about the integrity of self-certified quality control systems in generic drug manufacturing, with the next FDA inspection of Lupin's Pithampur, India facility expected to determine whether this was an isolated batch issue or a systemic manufacturing failure.MorningstarLupin Pharmaceuticals Recalls 2.5 Million Bottles of Prescription Eye DropsLupin Pharmaceuticals voluntarily recalled more than 2.5 million bottles of prescription prednisolone acetate ophthalmic suspension eye drops it manufactured, initiating the recall on June 4. The FDA reported the recall, citing the potential presence of a foreign substance in certain bottles of the medication used to treat eye allergies and inflammation. This marks a significant quality control issue for the pharmaceutical company affecting a widely prescribed ophthalmic product.Fox BusinessMillions of prescription eye drops recalled nationwide over contamination concernsLupin Pharmaceuticals Inc. has voluntarily recalled 2,530,182 bottles of prednisolone acetate ophthalmic suspension USP, 1% (a prescription steroid eye medication) after foreign material was identified in certain lots, with the FDA classifying the action as a Class II recall on June 30. The affected products were manufactured by Lupin Limited in Pithampur, India, and distributed nationwide across 5 mL, 10 mL, and 15 mL bottles. A Class II recall indicates use of the product may cause temporary or medically reversible adverse health consequences, with expiration dates beginning in July 2026 and extending beyond October 2026.New York PostEye drop recall in US affects 2.5 million bottles after contamination scare at India manufacturing plantLupin Pharmaceuticals Inc. is voluntarily recalling approximately 2.5 million bottles of Prednisolone Acetate Ophthalmic Suspension eye drops due to the potential presence of a foreign substance. The recall, initiated on June 4 and classified as a Class II recall by the FDA on June 30, affects 5-mL, 10-mL, and 15-mL bottles manufactured at a Lupin Limited facility in Pithampur, India. The FDA is advising consumers to stop using the recalled products immediately, as they pose a moderate risk of causing temporary or medically reversible health problems.