Alembic Pharmaceuticals Limited: Drug Recall

Recall #D-0566-2025 · 07/25/2025

Class II: Risk

Recall Details

Recall Number: D-0566-2025
Classification: Class II
Product Type: Drug
Recalling Firm: Alembic Pharmaceuticals Limited
Status: Ongoing
Date Initiated: 07/25/2025
Location: Panchmahal, N/A, India
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,492 bottles

Reason for Recall

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Product Description

Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31

Distribution Pattern

Nationwide in the USA.

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 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 II: Risk 05/07/2025

Failed Impurities/Degradation Specifications
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.