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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

Chlorpromazine Hydrochloride Tablets Recalled for Foreign Micro-organism

Agency Publication Date: September 15, 2025
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Summary

Amerisource Health Services LLC is recalling 6,400 cartons of Chlorpromazine Hydrochloride Tablets, a prescription medication used to treat certain mental and emotional disorders. The recall was initiated because a micro-organism was detected on a lot of polyester coil used in the product's packaging at the manufacturing site. Although no micro-organisms were found on the actual tablets, the company is voluntarily recalling multiple strengths (25 mg, 50 mg, 100 mg, and 200 mg) as a precaution. If you use this medication, contact your healthcare provider or pharmacist to discuss your treatment.

Risk

The presence of a micro-organism in the packaging material creates a potential risk of product contamination. While no bacteria were found on the tablets themselves, contaminated packaging could theoretically introduce foreign substances into the medication, potentially leading to infection or other adverse health effects.

What You Should Do

  1. Check your medication packaging for Chlorpromazine Hydrochloride Tablets in 25 mg, 50 mg, 100 mg, or 200 mg strengths packaged in blisterpacks.
  2. Identify if your product is affected by checking the lot numbers and expiration dates printed on the carton or individual blister strips. See the Affected Products section below for the full list of affected codes.
  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 (1-888-SAFEFDA) 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, 25 mg
Variants: 25 mg, Tablet, 50 (5x10) blisterpacks, 100 (10x10) blisterpacks
Lot Numbers:
1020919 (Exp 09/30/2026)
1021133 (Exp 09/30/2026)
1021447 (Exp 10/31/2026)
1021741 (Exp 11/30/2026)
1022202 (Exp 11/30/2026)
1022474 (Exp 12/31/2026)
1020460 (Exp 08/31/2026)
1022417 (Exp 12/31/2026)
NDC:
60687-430-65
60687-430-11
60687-430-01

Distributed by American Health Packaging, Columbus, Ohio 43217.

Product: chlorproMAZINE Hydrochloride Tablets, USP, 50 mg
Variants: 50 mg, Tablet, 100 (10x10) blisterpacks
Lot Numbers:
1022159 (Exp 12/31/2026)
1023299 (Exp 03/31/2027)
1024057 (Exp 04/30/2027)
NDC:
60687-441-01
60687-441-11

Distributed by American Health Packaging, Columbus, Ohio 43217.

Product: chlorproMAZINE Hydrochloride Tablets, USP, 100 mg
Variants: 100 mg, Tablet, 100 (10x10) blisterpacks
Lot Numbers:
1021652 (Exp 10/31/2026)
1022539 (Exp 01/31/2027)
1023666 (Exp 03/31/2027)
NDC:
60687-452-01
60687-452-11

Distributed by American Health Packaging, Columbus, Ohio 43217.

Product: chlorproMAZINE Hydrochloride Tablets, USP, 200 mg
Variants: 200 mg, Tablet, 100 (10x10) blisterpacks
Lot Numbers:
1021640 (Exp 10/31/2026)
1022639 (Exp 01/31/2027)
NDC:
60687-463-01
60687-463-11

Distributed by American Health Packaging, Columbus, Ohio 43217.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97533
Status: Active
Manufacturer: Amerisource Health Services LLC
Sold By: American Health Packaging; Pharmacies
Manufactured In: United States
Units Affected: 4 products (2,708 cartons; 1,062 cartons; 1,757 cartons; 873 cartons)
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 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.