FDA recall D-0566-2025

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

Reason for recall

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

Distribution

Nationwide in the USA.

Key facts

Status

Ongoing

Initiation date

2025-07-25

Report date

2025-08-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Panchmahal, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0566-2025