Alembic bromfenac eye drops recalled for failed impurity testing
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.
From the FDA notice · Read the official notice ↗ · All Alembic Pharmaceuticals recalls
What to do
- 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.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- 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.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
Details
- Illnesses reported
- None reported
- Manufactured in
- 550 Hills Dr Ste 104b, Bedminster, NJ, United States
- Classification
- Class II
- Recall number
- 98647
In the FDA's words
- Description
- 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. Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing. Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026. Distribution: Nationwide in the USA
- Hazard
- Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.