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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Zydus Chlorpromazine Hydrochloride Tablets Recalled for Excessive Impurity

Agency Publication Date: April 10, 2025
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Summary

Zydus Pharmaceuticals (USA) Inc. is recalling 3,144 bottles of chlorproMAZINE Hydrochloride Tablets (10 mg), a medication used to treat certain mental/mood disorders and severe nausea. The recall was initiated because testing detected an impurity called N-Nitroso-Desmethyl Chlorpromazine at levels exceeding the recommended interim limit. This recall affects 100-count bottles distributed across 18 states.

Risk

The presence of nitrosamine impurities above acceptable limits may increase the risk of cancer if consumed over a long period of time. There are currently no reports of adverse events related to this recall.

What You Should Do

  1. The recalled medication is chlorproMAZINE Hydrochloride Tablets, USP 10 mg, sold in 100-count bottles labeled with NDC 70710-1129-1.
  2. Identify the affected product by checking the bottle label for lot number Z400069 and an expiration date of 12/31/2025.
  3. 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.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 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
๐Ÿ—‘๏ธ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 10 mg (100 Tablets bottles)
Variants: 10 mg, Tablets
Lot Numbers:
Z400069 (Exp 12/31/2025)
NDC:
70710-1129-1

Manufactured by: Zydus Lifesciences Ltd., Baddi, India; Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96626
Status: Active
Manufacturer: Zydus Pharmaceuticals (USA) Inc
Sold By: Pharmacies
Manufactured In: India
Units Affected: 3144 bottles, pack size: 100's Count
Distributed To: Mississippi, Alabama, Tennessee, Vermont, Ohio, North Dakota, Minnesota, Wisconsin, South Carolina, Arkansas, Florida, Indiana, Louisiana, New Jersey, Arizona, Texas, Kentucky, Pennsylvania

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 ยท 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.