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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 Ph…

Failed Impurities/Degradation Specifications: out of specification at the time of testing i.e. 20th month stability testing.

Class II Medicine & devices FDA April 8, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
ALEMBIC PHARMACEUTICALS, INC. — Bedminster, NJ
Severity
Class II — moderate
Reported
April 8, 2026
Status
Ongoing
Source
FDA

Where it went

Nationwide in the USA

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