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FDA Recalls 2.5M Eye Drops for Foreign Substance Danger
10 Jul
Summary
- Over 2.5 million bottles of eye drops recalled nationwide.
- Lupin Pharmaceuticals recalled product due to unknown foreign substance.
- Recall is Class II, indicating potential adverse health consequences.

The Food and Drug Administration announced a significant nationwide recall affecting over 2.5 million bottles of prednisolone acetate eye drops. The recall was initiated on June 4 by Lupin Pharmaceuticals due to the presence of an unspecified foreign substance within the product.
This Class II recall signifies a risk of adverse health consequences if the contaminated eye drops are used. The affected bottles, manufactured by India-based Lupin, are available in 5 mL, 10 mL, and 15 mL quantities.
The FDA strongly advises individuals who rely on these eye drops not to simply discontinue use. Instead, they should immediately consult their eye doctor or pharmacist to discuss alternative treatments and ensure continuity of care for their specific eye conditions.