FDA Recall D-0566-2025

Alembic Pharmaceuticals Limited · Panchmahal, N/A

Class II Ongoing 293 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: Lot: 2305015142, Exp. Date: 9/30/2025

Quantity: 9,492 bottles

Reason for recall

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

Recall record

Recall number: D-0566-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA.
Recall initiated: 2025-07-25
Classified by FDA Center: 2025-08-01
FDA published: 2025-08-13
Recalling firm: Alembic Pharmaceuticals Limited
Firm location: Panchmahal, N/A, India

Drug identification

Brand name(s): DOXEPIN HYDROCHLORIDE
Generic name(s): DOXEPIN HYDROCHLORIDE
Manufacturer(s): Alembic Pharmaceuticals Inc.
NDC(s): 62332-637, 62332-638, 62332-645, 62332-639, 62332-640
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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