FDA Drugs recall ·
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile… recall
- Recall number
- D-0447-2025
- Date
- (initiated May 7, 2025)
- Company / brand
- Alembic Pharmaceuticals Limited
Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol, Panchmahal, N/A, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- N/A
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Bromfenac Ophthalmic Solution 0.09%, 1.7 mL bottle, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Manufactured by Alembic Pharmaceuticals Limitied, Gujarat, India, Made in India, NDC 62332-508-17
Why was it recalled?
Failed Impurities/Degradation Specifications
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot 7230309, Exp Date: 5/31/2025; Lot 7230310, Exp Date: 5/31/2025; Lot 7230311, Exp Date: 5/31/2025
Distribution
US Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0447-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.