The US Food and Drug Administration (FDA) has recalled 2,530,182 bottles of prescription eye medication after identifying potential contamination issues. According to reports from The Hill, Lupin Pharmaceuticals Inc voluntarily initiated the recall of Prednisolone Acetate Ophthalmic Suspension, USP, 1 per cent, which is commonly used to reduce redness, itching and swelling caused by eye infections and other eye conditions. The affected product includes 5 ml, 10 ml and 15 mL bottles manufactured by Lupin Limited at its facility in Pithampur, Madhya Pradesh, India. The recall affects National Drug Code numbers 70748-332-02, 70748-332-03, and 70748-332-04, as reported by the FDA. The recall was initiated on June 4 and officially classified as a Class II recall on Tuesday, June 30.
The FDA classified the recall as a Class II recall due to the potential presence of a foreign substance in the eye drops. As reported by The Hill, the recall began early last month and affects several lot numbers across all three bottle sizes. Since it is a prescription medicine, patients using the affected medication are advised to check whether their bottle belongs to one of the affected lots before continuing treatment. The FDA officially classified the recall as a Class II recall on Tuesday, June 30, applying to products where use may cause temporary or medically reversible adverse health consequences, or where the probability of serious health consequences is considered remote.
According to the FDA, a Class II recall applies to products where use may cause temporary or medically reversible adverse health consequences, or where the probability of serious health consequences is considered remote. The FDA classifies product recalls into three categories: Class I (most serious, reasonable chance of serious health problems), Class II (temporary or medically reversible consequences), and Class III (products unlikely to cause adverse health consequences but don't meet standards).
This recall follows other recent pharmaceutical recalls in the US market. In March 2026, Cipla's US subsidiary recalled more than 400 cartons of generic anti-cancer medicine due to manufacturing issues, while in August 2025, Glenmark Pharmaceuticals recalled 55,560 units of Carvedilol tablets after detecting nitrosamine impurities above acceptable levels. The FDA has also previously classified recalls by Alembic Pharmaceuticals and Sun Pharma due to manufacturing-related issues.
