Lupin recalls 2.5 million bottles of prednisolone eye drops over contamination risk

Lupin Pharmaceuticals has voluntarily recalled over 2.5 million bottles of prednisolone acetate ophthalmic suspension after detecting foreign substances, raising concerns about potential eye irritation and secondary infections, with clinicians advised to check lot numbers and replace affected products.

Lupin Pharmaceuticals has voluntarily recalled more than 2.5 million bottles of prednisolone acetate ophthalmic suspension, USP, 1%, after a foreign substance was detected in certain lots. According to the FDA’s enforcement report, the action was posted on 4 June 2026 and later classified as a Class II recall on 30 June, indicating that use could cause temporary or medically reversible harm, although serious effects are considered unlikely. The recall covers 5 mL, 10 mL and 15 mL bottles with expiry dates running from July 2026 to March 2028.

For veterinarians in practice, the key point is that this is not a routine labelling issue: the product is applied directly to the eye, where contamination can trigger irritation, inflammation, corneal injury and, in some cases, secondary infection, according to Clinical Spectrum and the company’s recall notice. The affected generic product is widely used in inflammatory ocular conditions, so bottles may still be in clinics, discharge packs or clients’ homes.

Clinicians should advise clients to check the NDC and lot number against the FDA recall list, stop using any affected bottle and contact the dispensing pharmacy or prescriber for a replacement. In patients using steroid drops after ocular surgery or for chronic inflammation, abrupt discontinuation should be avoided without veterinary or specialist guidance, because rebound inflammation can be clinically significant.

Image Source: Lupin Pharmaceuticals