Reported Aug 13, 2025 · Ongoing
Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only, Manufactured by: Alembic Pharmaceuticals Limited,…
Alembic Pharmaceuticals Limited
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Alembic Pharmaceuticals Limited · Formulation Division, Village Panelav, P.O. Tajpura, Near Baska, Taluka Halol · Panchmahal, N/A · N/A
Is this the product you have?
- Doxepin Hydrochloride Capsules, USP, 10 mg, 100 Capsules, Rx only
- Manufactured byAlembic Pharmaceuticals Limited, Panela v 389350, Gujarat, India
- Manufactured forAlembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-637-31
- Lot codes and dates
- Lot2305015142, Exp
- Date9/30/2025
- Amount recalled
- 9,492 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
This product could cause temporary or reversible health problems — stop using it.
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