FDAHealthMarch 18, 2026
ALEMBIC PHARMACEUTICALS, INC. — Bromfenac Ophthalmic Solution 0.07%, 3 ml, Rx only, Sterile, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, Made in India, Manufactured by:
⚠️ Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- March 18, 2026
Nationwide in the USA
What's affected?
- 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.
- Brand
- BROMFENAC SODIUM
- Lot code
- 7240184
Additional details
Lot # 7240184, 7240185, 7240186, 7240187, Exp Date: 3/31/2026; Lot # 7240278, Exp Date: 5/31/2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated
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