Medications & Supplements/Prescription Drugs

Doxepin Hydrochloride Capsules Recalled for Nitrosamine Impurity

Agency Publication Date: August 1, 2025

Summary

Alembic Pharmaceuticals Limited is voluntarily recalling 9,492 bottles of Doxepin Hydrochloride Capsules, USP (10 mg), a prescription medication used to treat depression and anxiety. The recall was initiated because testing found a Nitrosamine Drug Substance Related Impurity (NDSRI) above the FDA's proposed interim limit. Consumers should contact their doctor or pharmacist for guidance before stopping the medication.

Risk

Nitrosamines are impurities that may increase the risk of cancer if people are exposed to them above acceptable levels over long periods of time. While no immediate health risks have been reported, this specific batch exceeds safety thresholds established for long-term use.

What You Should Do

This recall affects Doxepin Hydrochloride Capsules, USP, 10 mg, sold in 100-count bottles under NDC 62332-637-31 and manufactured for Alembic Pharmaceuticals, Inc.
Identify affected bottles by checking for lot number 2305015142 with an expiration date of 9/30/2025.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Doxepin Hydrochloride Capsules, USP, 10 mg (100 Capsules)

Variants: 10 mg, Capsule

Lot Numbers:

2305015142 (Exp. 9/30/2025)

NDC:

62332-637-31

Manufactured by Alembic Pharmaceuticals Limited, Gujarat, India; Quantity: 9,492 bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97323

Status: Active

Manufacturer: Alembic Pharmaceuticals Limited

Sold By: Retail Pharmacies; Hospitals

Manufactured In: India

Units Affected: 9,492 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Doxepin Hydrochloride Capsules, USP, 10 mg, sold in 100-count bottles under NDC 62332-637-31 and manufactured for Alembic Pharmaceuticals, Inc.

Identify affected bottles by checking for lot number 2305015142 with an expiration date of 9/30/2025.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.