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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

Major Pharmaceuticals Chlorpromazine Tablets Recalled for Excessive Impurities

Agency Publication Date: October 7, 2025
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Summary

The Harvard Drug Group LLC (dba Major Pharmaceuticals and Rugby Laboratories) has recalled 6,086 blister packs of Major brand ChlorproMAZINE Hydrochloride Tablets, a prescription antipsychotic medication, due to the presence of N-Nitroso Desmethyl Chlorpromazine at levels above the recommended intake limit. The recall affects 25 mg, 50 mg, 100 mg, and 200 mg strengths packaged in 50-count and 100-count blister packs. Consumers should check their medicine for the affected lot numbers and expiration dates, which range from September 2025 to June 2026.

Risk

The tablets contain a nitrosamine impurity (N-Nitroso Desmethyl Chlorpromazine) that exceeds safe daily intake levels; long-term exposure to elevated levels of nitrosamines is associated with an increased risk of cancer.

What You Should Do

  1. Check your medication packaging for Major brand ChlorproMAZINE Hydrochloride Tablets in 25 mg, 50 mg, 100 mg, or 200 mg strengths.
  2. Compare the NDC codes and lot numbers on your blister packs against the following list: NDC 0904-7130-06 (Lots N01943, N02025), NDC 0904-7130-61 (Lots N01954, N02024), NDC 0904-7131-61 (Lots N02009, N02026), NDC 0904-7132-61 (Lots N01920, N02023, N02202), and NDC 0904-7133-61 (Lots N01928, N02008, N02071).
  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.

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: Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg (50 Tablets)by Major Pharmaceuticals
Variants: 25 mg, Tablet
UPC Codes:
00309047130061
Lot Numbers:
N01943 (Exp 02/28/2026)
N02025 (Exp 02/28/2026)
NDC:
0904-7130-06

5x10 blister package

Product: Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg (100 Tablets)by Major Pharmaceuticals
Variants: 25 mg, Tablet
UPC Codes:
00309047130610
Lot Numbers:
N01954 (Exp 11/30/2025)
N02024 (Exp 02/28/2026)
NDC:
0904-7130-61

10x10 blister package

Product: Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg (100 Tablets)by Major Pharmaceuticals
Variants: 50 mg, Tablet
UPC Codes:
00309047131617
Lot Numbers:
N02009 (Exp 02/28/2026)
N02026 (Exp 02/28/2026)
NDC:
0904-7131-61

10x10 blister package

Product: Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg (100 Tablets)by Major Pharmaceuticals
Variants: 100 mg, Tablet
UPC Codes:
00309047132614
Lot Numbers:
N01920 (Exp 12/31/2025)
N02023 (Exp 02/28/2026)
N02202 (Exp 06/30/2026)
NDC:
0904-7132-61

10x10 blister package

Product: Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg (100 Tablets)by Major Pharmaceuticals
Variants: 200 mg, Tablet
UPC Codes:
00309047133611
Lot Numbers:
N01928 (Exp 09/30/2025)
N02008 (Exp 03/21/2026)
N02071 (Exp 02/28/2026)
NDC:
0904-7133-61

10x10 blister package

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97584
Status: Active
Manufacturer: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Sold By: pharmacies
Manufactured In: United States
Units Affected: 5 products (2064 blister packs; 1256 blister packs; 506 blister packs; 866 blister packs; 1394 blister packs)
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.