Reported Jun 4, 2025 · Ongoing

Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc.,…

Alembic Pharmaceuticals Limited

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Alembic Pharmaceuticals Limited · Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol · Panchmahal, N/A · N/A

Is this the product you have?

  • Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile
  • Manufactured forAlembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Lot codes and dates
  • Lot 7230309
  • Exp Date
    • 5/31/2025
    • Lot 7230310
  • Exp Date
    • 5/31/2025
    • Lot 7230311
  • Exp Date5/31/2025
Amount recalled
N/A

Where it was sold

  • Nationwide

Why it was recalled

Failed Impurities/Degradation Specifications

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Data as of Sep 19, 5:54 PM UTC

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