Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharm...
FDA Recall #D-0566-2025 — Class II — July 25, 2025
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
Reason for Recall
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Recalling Firm
Alembic Pharmaceuticals Limited — Panchmahal, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
9,492 bottles
Distribution
Nationwide in the USA.
Code Information
Lot: 2305015142, Exp. Date: 9/30/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated