Alembic Pharmaceuticals Limited: Drug Recall

Recall #D-0447-2025 · 05/07/2025

Class II: Risk

Recall Details

Recall Number: D-0447-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Alembic Pharmaceuticals Limited
Status: Ongoing
Date Initiated: 05/07/2025
Location: Panchmahal, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: N/A

Reason for Recall

Failed Impurities/Degradation Specifications

Product Description

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

Distribution Pattern

US Nationwide

Other Recalls by Alembic Pharmaceuticals Limited

Class III: Low Risk 12/16/2025

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class III: Low Risk 10/10/2025

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Class II: Risk 07/25/2025

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Class II: Risk 05/09/2025

Presence of Foreign Tablets/Capsules; customer complaint found one Tadalafil 5mg tablet inside a sealed 500-count bottle of Celecoxib 200mg capsule
Class I: Dangerous 03/17/2021

Labeling: Label-mixup

View all recalls by Alembic Pharmaceuticals Limited →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.