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Bromfenac Ophthalmic Solution 0.07%
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DRUG RECALLMODERATE

Bromfenac Ophthalmic Solution 0.07%

Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07% (NDC 62332-583-03) due to failed impurities and degradation specifications.

What to do

Stop using this medication immediately. Contact your healthcare provider or pharmacist for a replacement prescription or alternative treatment.

Recalled
Listed
Updated
Agency
FDA
Firm
ALEMBIC PHARMACEUTICALS, INC.
Recall ID
98647
Status
ONGOING

Why it was recalled

Alembic Pharmaceuticals is recalling Bromfenac Ophthalmic Solution 0.07%, 3 ml vials (NDC 62332-583-03) due to failed impurities and degradation specifications detected during 20-month stability testing. The affected product was manufactured by Alembic Pharmaceuticals Limited in Gujarat, India. Consumers should stop using this medication and contact their healthcare provider or pharmacist for a replacement.

Is mine affected?

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

Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile

NDC / UPC
NDC 62332-583-03

Timeline

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

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification