The affected products carry National Drug Codes (NDCs) 70748-332-02, 70748-332-03, and 70748-332-04 and include dozens of lot numbers with expiration dates ranging from July 31, 2026, through March 31, 2028. The recall, tracked under FDA recall number D-0655-2026, covers products distributed nationwide through pharmacies and healthcare providers, including major retail chains such as Walgreens, Kroger, and CVS, as noted by GoodRx and confirmed by FDA records.

The recall affects 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension, USP, 1%, packaged in 5-milliliter, 10-milliliter, and 15-milliliter bottles, according to the U.S. Food and Drug Administration’s (FDA) enforcement report.

Lupin Pharmaceuticals Inc., the U.S. affiliate of Lupin Limited, initiated the voluntary recall on June 4, 2026, after the company identified a potential presence of a foreign substance in certain lots of the steroid eye drops. The FDA classified the recall as Class II on June 30, 2026, indicating that the product may cause temporary or medically reversible adverse health consequences with a remote probability of serious harm. The agency’s enforcement documentation specifies the reason for the recall as the “presence of foreign substance” but does not disclose the nature of the contaminant or how it entered the manufacturing process at Lupin’s facility in Pithampur, India.

The recalled medication is a prescription-only steroid used to treat eye inflammation, allergies, infections, irritation, redness, and swelling. It is commonly prescribed after eye surgery, injuries, allergic reactions, or infections to reduce inflammation, according to clinical references including the Mayo Clinic. Because the product is an ophthalmic suspension intended for sterile intraocular use, contamination raises significant safety concerns, FDA officials said. As of the latest reports, it remains unclear whether any adverse events or injuries have been associated with the contaminated batches.

The recall affects multiple lots spanning different distribution periods, and consumers and healthcare providers are advised to verify the specific lot number printed near the expiration date to determine if a bottle is subject to the recall. The FDA cautions that matching the NDC code alone is insufficient for identification. Lupin has notified customers by letter, according to the FDA enforcement report cited by Fox Business, but had not issued a formal press release at the time of reporting.

Medical experts and FDA guidance emphasize that patients should not abruptly discontinue use of prescribed steroid eye drops without consulting their healthcare provider, as sudden cessation can lead to complications in managing eye inflammation. Patients who suspect they have a recalled bottle are encouraged to contact their prescribing doctor or pharmacist to confirm the lot number and discuss replacement options or alternative treatments. Physicians can arrange for replacements from unaffected lots or prescribe alternative medications if needed.

Consumers experiencing eye pain, redness, irritation, or changes in vision after using the product are urged to seek prompt medical evaluation. Adverse reactions or quality problems can be reported directly to Lupin Pharmaceuticals at 1-800-399-2561 or to the FDA’s MedWatch Adverse Event Reporting program at 1-800-332-1088.

Lupin’s Prednisolone Acetate Ophthalmic Suspension is part of the U.S. prescription drug supply chain, and the recall impacts a broad segment of the market. The medication is sold under various brand labels but shares the same active ingredient and NDC identifiers. The recall remains ongoing as the FDA continues to monitor the situation and coordinate with Lupin to address the contamination concerns.

The FDA classified the recall as Class II on June 30, indicating that exposure to the contaminated eye drops could cause temporary or medically reversible eye injuries, such as inflammatory responses, mechanical irritation, corneal injury, or secondary ocular inflammation, officials said. The contamination was identified as foreign particulate matter found in certain lots, based on a single market complaint that prompted a Health Hazard Assessment by the FDA, sources confirmed.

The recall affects 2,530,182 bottles of prednisolone acetate ophthalmic suspension, USP, 1%, in 5 mL, 10 mL, and 15 mL sizes distributed nationwide through pharmacies and healthcare providers, according to FDA enforcement reports and Lupin Pharmaceuticals statements.

Lupin initiated the voluntary recall on June 6, two days after the FDA first flagged the issue on June 4, according to regulatory filings and media reports. The recall remains ongoing, with products actively being removed from the market, and additional notifications expected as the process continues. The affected lots include 132 batches of 5-mL bottles, 36 batches of 10-mL bottles, and 22 batches of 15-mL bottles, with expiration dates ranging from July 31, 2026, to as late as March 31, 2028, according to FDA summaries and Lupin’s recall notice. Only specific lots, including item numbers #1315797 and #1315798, are subject to the recall, not all Lupin eye-drop products, the company clarified.

Patients using the recalled prednisolone acetate drops are advised to stop use immediately and consult their healthcare providers for alternatives, according to FDA guidance. Eye-care providers and pharmacies have been instructed to quarantine affected inventory, discontinue dispensing the product, notify staff and patients, and contact the designated recall coordinator at RecallNotification@hilco.com to facilitate removal and replacement of the recalled lots, officials said. Consumers and clinicians are also encouraged to report any adverse events possibly linked to the drops through the FDA’s MedWatch system.

Prednisolone acetate 1% ophthalmic suspension is a corticosteroid widely prescribed for short-term treatment of ocular inflammation caused by allergies, surgery, or injury, sources noted. Unlike some previous eye-drop recalls involving sterility failures, this recall specifically concerns foreign particulate contamination rather than a broad lack of sterility assurance, according to FDA enforcement reports. As of the latest available data, no adverse events or injuries have been formally reported to Lupin or the FDA in connection with this recall, according to coverage summarizing FDA data.

Lupin Pharmaceuticals Inc., a U.S. subsidiary of India-based Lupin Limited, is a global generic drug manufacturer with a significant presence in ophthalmic and cardiovascular medicines. The company has previously conducted voluntary recalls, including a nationwide recall in 2021 of certain irbesartan and irbesartan/hydrochlorothiazide tablet lots due to impurities exceeding acceptable limits. In that case, Lupin cited an abundance of caution and reported no associated illnesses, a posture consistent with its current recall of prednisolone acetate eye drops.

The recall highlights ongoing regulatory scrutiny of generic drug manufacturers and the critical importance of stringent quality-control measures in the production of sterile and semi-sterile ophthalmic products, according to experts cited in FDA and media reports. This action comes amid a broader context of recent eye-drop safety concerns, including a separate voluntary recall of over 3.1 million over-the-counter eye-drop bottles from another manufacturer due to sterility issues. Despite the size of this recall, health authorities emphasize that most unaffected eye-drop products remain safe when obtained from reputable manufacturers and used as directed.