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FDA Recalls 2.5M Bottles of Eyedrops Over 'Foreign Material'
Newser • • business
Key Points:
- Lupin Pharmaceuticals has recalled over 2.5 million bottles of its prednisolone acetate 1% steroid eye drops due to the presence of foreign material in some bottles, according to an FDA Class II recall notice.
- The recall affects multiple lot numbers of 5, 10, and 15 mL bottles with expiration dates starting July 2026; the drops are prescription-only and made in India for nationwide distribution.
- The FDA classifies the recall as Class II, indicating a low risk of serious harm but potential for temporary or reversible health issues.
- Patients using these eye drops are advised to check lot numbers against the FDA recall list and consult healthcare providers before discontinuing use.
- The recall began on June 4 and was reclassified as Class II on June 30, with specific National Drug Codes provided for the affected bottle sizes.
