FDA-Drug2026-04-08Class IICHEMICAL
Alembic Bromfenac Ophthalmic Solution recalled for failed impurity specifications
What this means
Alembic Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.07% because the medication failed purity and degradation tests during stability testing at 20 months. The affected eye drops may contain higher-than-acceptable impurity levels, which could affect safety and effectiveness.
- Check your Bromfenac eye drops bottle for lot numbers 7240184, 7240185, 7240186, 7240187 (expires 3/31/2026) or 7240278 (expires 5/31/2026).
- Do not use the product if it matches these lot numbers.
- Contact your pharmacy or prescriber for a replacement or alternative medication.
- If you have used this product and experience eye irritation or vision changes, contact your eye care provider.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Manufactured in
550 Hills Dr Ste 104b, Bedminster, NJ, United States
Products
Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by: Alembic Pharmaceuticals Limited, Karakhadi- 391 450, Gujarat, India NDC 62332-583-03.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=98647Want us to check the next one for you?
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