Doxepin Hydrochloride Capsules recalled over manufacturing violations

Recall date

July 25, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Alembic Pharmaceuticals Limited recalls Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Pa…

Recall number

D-0566-2025

FDA classification

Class II

Brand / firm

Alembic Pharmaceuticals Limited

Sold / distributed

Nationwide in the USA.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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