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prednisoLONE Acetate Ophthalmic Suspension 1%
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DRUG RECALLMODERATE

prednisoLONE Acetate Ophthalmic Suspension 1%

Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.

What to do

Stop using the affected ophthalmic suspension immediately and contact your healthcare provider or pharmacist for further guidance.

Recalled
Listed
Updated
Recall No.
D-0655-2026
Agency
FDA
Firm
Lupin Pharmaceuticals Inc.
Recall ID
99144
Status
ONGOING

Recall at a glance

Quantity recalled
2,530,182 bottles

Why it was recalled

Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. The affected products include the 5 mL, 10 mL, and 15 mL bottles.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (

Lot code
HA00937, HA00939, HA00941, HA00971, H00973, HA00975, 2026
NDC / UPC
NDC 70748-332-02, NDC 70748-332-03

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other Foreign Material recalls

Other recent recalls from Lupin Pharmaceuticals Inc.

All recalls from Lupin Pharmaceuticals Inc.

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Editorial summary by Recall Canary · summary updated 2026-07-01 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification