Medications & Supplements/Prescription Drugs

Chlorpromazine Hydrochloride Tablets Recalled for Impurity Levels

Agency Publication Date: December 23, 2024

Summary

Glenmark Pharmaceuticals Inc., USA has recalled 3,888 bottles of Chlorpromazine Hydrochloride (chlorpromazine) tablets, a prescription medication used to treat certain mental/mood disorders and nausea/vomiting. The recall includes 100-count bottles of both 10mg and 25mg strengths. The recall was initiated because the product was found to contain an impurity called N-Nitroso-Desmethyl Chlorpromazine (NNDCI) at levels that exceed the current safety limits recommended by the FDA.

Risk

NNDCI is a type of nitrosamine impurity. These substances are classified as potential human carcinogens, meaning long-term exposure to levels above safety limits may increase the risk of cancer.

What You Should Do

This recall affects chlorproMAZINE Hydrochloride Tablets, USP, in 10mg (NDC 68462-861-01) and 25mg (NDC 68462-862-01) strengths, sold in 100-count bottles manufactured for Glenmark Pharmaceuticals Inc.
Identify your medication by checking the lot numbers on the bottle label. Affected 10mg tablets have lot numbers 17230132 (Exp 12/2024) or 17230449 (Exp 01/2025). Affected 25mg tablets have lot number 17230133 (Exp 12/31/2024).
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: chlorproMAZINE Hydrochloride Tablets, USP (10mg, 100-count bottle)

Variants: 10mg, 100-count bottle

Lot Numbers:

17230132 (Exp 12/2024)

17230449 (Exp 01/2025)

NDC:

68462-861-01

RX only; Product of India; Manufactured for Glenmark Pharmaceuticals Inc., NJ.

Product: chlorproMAZINE Hydrochloride Tablets, USP (25 mg, 100-count bottle)

Variants: 25mg, 100-count bottle

Lot Numbers:

17230133 (Exp 12/31/2024)

NDC:

68462-862-01

RX only; Product of India; Manufactured for Glenmark Pharmaceuticals Inc., NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 95936

Status: Active

Manufacturer: Glenmark Pharmaceuticals Inc., USA

Sold By: Pharmacies

Manufactured In: India

Units Affected: 3,888

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 chlorproMAZINE Hydrochloride Tablets, USP, in 10mg (NDC 68462-861-01) and 25mg (NDC 68462-862-01) strengths, sold in 100-count bottles manufactured for Glenmark Pharmaceuticals Inc.

Identify your medication by checking the lot numbers on the bottle label. Affected 10mg tablets have lot numbers 17230132 (Exp 12/2024) or 17230449 (Exp 01/2025). Affected 25mg tablets have lot number 17230133 (Exp 12/31/2024).

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: chlorproMAZINE Hydrochloride Tablets, USP (10mg, 100-count bottle)

Variants: 10mg, 100-count bottle

Lot Numbers:

17230132 (Exp 12/2024)

17230449 (Exp 01/2025)

NDC:

68462-861-01

RX only; Product of India; Manufactured for Glenmark Pharmaceuticals Inc., NJ.

Product: chlorproMAZINE Hydrochloride Tablets, USP (25 mg, 100-count bottle)

Variants: 25mg, 100-count bottle

Lot Numbers:

17230133 (Exp 12/31/2024)

NDC:

68462-862-01

RX only; Product of India; Manufactured for Glenmark Pharmaceuticals Inc., NJ.