Doxepin Hydrochloride Capsule
FDA Recall NDC 62332-640
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Doxepin Hydrochloride (NDC 62332-640). A significant event, classified as Class II, was initiated on Jul 25, 2025 by Alembic Pharmaceuticals Inc.. The reported reason for this action was: "CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.
Jul 25, 2025
Aug 13, 2025
9,492 bottles
Recall Profile & Regulatory Data
Event ID
97323
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Alembic Pharmaceuticals Limited
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
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
Batch or Lot Expiration Information
Lot# Lot: 2305015142, Exp. Date: 9/30/2025
Affected Packages Involved in this Recall
62332-637-31Product
62332-637-91Product
62332-638-31Product
62332-638-91Product
62332-645-31Product
62332-645-91Product
62332-639-31Product
62332-639-91Product
62332-640-31Product
62332-640-91Product
2305015142Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
