Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance
Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving a foreign substance in an ophthalmic suspension—a risk-of-harm product where potential for serious injury (eye infection, vision impairment) exists. No illnesses or injuries are reported in the source, but the hazard is not purely theoretical given the nature of foreign contaminants in sterile eye medications.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% (a sterile eye drop medication available in 5 mL, 10 mL, and 15 mL bottles) due to the presence of a foreign substance. The product was manufactured by Lupin Limited in Pithampur, India and distributed nationwide in the United States.
Multiple lot numbers of the affected product have been identified, with expiration dates ranging from July 2026 through March 2028. A total of 2,530,182 bottles are involved in this recall. The specific identity of the foreign substance is not detailed in available information.
Patients who have this medication should contact their healthcare provider or pharmacist. Consumers should not use the recalled product and should return it to their pharmacy for proper disposal. Those with questions may contact Lupin Pharmaceuticals.
The recalled product
- Product
- PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
- Brand
- PREDNISOLONE ACETATE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Ophthalmic
- Hazard
- foreign-substance
- contamination
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lots: a) HA00937
- HA00939
- HA00941
- HA00971
- H00973
- HA00975
- Expires: 7/31/2026
- HA00987
- HA00989
- HA00991
- HA01010
- HA01012
- HA01014
- HA01016
- HA01048
- Expires: 8/31/2026
- HA01120
- HA01137
- HA01129
- HA01138
Distribution
Distributed nationwide across the United States.
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