Prescription eye drops recalled nationwide by FDA

The US Food and Drug Administration (FDA) announced a nationwide recall of millions of bottles of prescription steroid eye drops because of the potential contamination by “a foreign substance,” according to the agency’s enforcement report.

The product description in the report is listed as follows: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA

The FDA is recalling 5 (NDC 70748-332-02), 10 (NDC 70748-332-03), and 15 (70748-332-04) mL bottles of the steroid. The quantity recalled is 2,530,182 bottles. The recall number is D-0655-2026.

The FDA reported that patients using the contaminated drops may experience temporary or medically reversible adverse health consequences, a Class II recall. The agency advised that use of the affected eye drops be stopped immediately,

The enforcement report can be viewed using this link.

Patients and physicians can obtain specific information about the lots affected.

The recall affects 2,530,182 bottles of eye drops manufactured by Lupin Limited. The recall number is D-0655-2026.