FDA recall, , Moderate risk
Lupin Prednisolone Acetate Ophthalmic Suspension
The ophthalmic suspension contains a foreign substance.
Summary by Recall Canary from the FDA notice
What happened
Lupin Pharmaceuticals Inc., based in Naples, Florida, is recalling prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, because of the presence of a foreign substance. The recall affects products manufactured by Lupin Limited in Pithampur, India, and was initiated on June 4, 2026.
The product was distributed nationwide in the U.S. and was added to the FDA's Enforcement Report on June 30, 2026. The recall involves 2,530,182 bottles of the ophthalmic suspension.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Affected if its NDC and lot code are listed under that product.
An NDC (National Drug Code) is usually printed on the drug's label.
prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile
- NDC
- 70748-332-02
- 70748-332-03
- 70748-332-04
- Lot code
- HA00937
- HA00939
- HA00941
- HA00971
- H00973
- HA00975
Recall details
- Company began the recall
- Sold in
U.S. Nationwide
- Company
- Lupin Pharmaceuticals Inc.Naples, Florida
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99144
- Recall number
- D-0655-2026
- Quantity recalled
- 2,530,182 bottles
All recalls from Lupin Pharmaceuticals Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
