Lupin Pharmaceuticals Inc. has recalled 2,530,182 bottles of Prednisolone Acetate Ophthalmic Suspension USP 1% nationwide after FDA testing found a foreign substance in the product. The recall was initiated May 18, 2026, and classified as Class II by the FDA on June 30, 2026. No adverse events have been reported. The recall covers three bottle sizes across numerous lot codes with expiration dates from July 2026 through March 2028 — meaning many affected bottles are in active use right now.
What’s Being Recalled?
The recall covers Prednisolone Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, in three bottle sizes:
5 mL — NDC 70748-332-02
10 mL — NDC 70748-332-03
15 mL — NDC 70748-332-04
The full lot code list is extensive — patients should verify their specific NDC, lot number, and expiration date against the FDA’s enforcement report at fda.gov. The product was manufactured by Lupin Limited in Pithampur, India, and distributed nationwide through pharmacies. Prednisolone acetate ophthalmic suspension is a prescription corticosteroid eye drop commonly used to treat ocular inflammation after eye surgery and for allergic or inflammatory eye conditions.
Why Was This Product Recalled?
The FDA identified the presence of a foreign substance in the recalled eye drops. The specific nature of the foreign substance has not been publicly disclosed. The FDA’s Class II classification indicates that the probability of serious adverse health consequences is considered remote, but temporary or medically reversible adverse health effects are possible. Eye drops applied directly to the eye carry a higher risk from foreign material than most other product types.
What Should You Do?
Do not stop using your prednisolone acetate eye drops without first consulting your prescribing doctor, ophthalmologist, or pharmacist — particularly if you are using the drops following eye surgery or to manage an active inflammatory condition. Abruptly stopping a prescribed corticosteroid eye drop can cause a rebound inflammatory response. Contact your pharmacy or prescriber to check whether your specific bottle is affected and to arrange a replacement from an unaffected lot. Report any adverse reactions to the FDA MedWatch program at 1-800-332-1088 or fda.gov/safety/medwatch.
