Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Pan
Recalled August 13, 2025 · FDA recall D-0566-2025 · Alembic Pharmaceuticals
Hazard
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit. · FDA Class II
Units
9,492 bottles
Sold at
Nationwide in the USA.
Description
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
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
Manufacturer(s)
Alembic Pharmaceuticals Limited
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →