FDA-Drug2026-07-08Class IIPROCESSING DEFECT
Lupin Pharmaceuticals prednisolone acetate eye drops recalled for foreign substance contamination
Nationwide distributionDrugs
What this means
Lupin Pharmaceuticals is recalling multiple lots of prednisolone acetate ophthalmic suspension 1% (an anti-inflammatory eye drop) due to the presence of a foreign substance in some bottles. The affected lots were distributed nationwide. No injuries have been reported.
- Check if you have one of the affected lot numbers listed on the FDA website or your bottle.
- Do not use the product if you have an affected lot.
- Contact your pharmacist or doctor for a replacement or alternative medication.
- Return the recalled medication to your pharmacy.
The agency's original wording
Hazard
Presence of Foreign Substance
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
2,530,182 bottles
Manufactured in
5801 Pelican Bay Blvd Ste 500, N/A, Naples, FL, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0655-2026More Lupin recalls
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