Lupin recalls more than 2.5 million prescription eye drop bottles, citing possible contamination

Lupin Pharmaceuticals Inc. recalled more than 2.5 million bottles of prescription Prednisolone Acetate Ophthalmic Suspension in the United States on Thursday. The recall was initiated due to potential contamination with a foreign substance, raising sterility concerns, according to the U.S. Food and Drug Administration.

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.