Alembic Pharmaceuticals Limited 2025-06-04 Health serious FDA
Health · FDA · Recall #FDA-D-0447-2025
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for:… Recall
Issued June 4, 2025 · Alembic Pharmaceuticals Limited
In June 2025, Alembic Pharmaceuticals Limited recalled the Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for:…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications
What you should do
- 1 Stop using Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for:… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Alembic Pharmaceuticals Limited to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Alembic Pharmaceuticals Limited
- Category
- Health
- Recall date
- June 4, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide
- Recall number
- FDA-D-0447-2025
- Made in
- India
- Issuing agency
- FDA
In context
- Alembic Pharmaceuticals Limited has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.