HIGH

Major Pharmaceuticals Recalls Chlorpromazine Tablets Over Contamination

Major Pharmaceuticals announced a recall of 1,256 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall stems from the presence of N-Nitroso Desmethyl Chlorpromazine above safe intake levels. Consumers must stop using the product immediately and contact their healthcare provider for guidance.

Quick Facts at a Glance

Recall Date
September 12, 2025
Hazard Level
HIGH
Brands
Chlorpromazine Hydrochloride, Major Pharmaceuticals
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories or your healthcare provider for guidance. Notification method: Letter

Product Details

The recalled product is Chlorpromazine Hydrochloride Tablets, USP, 25 mg, packaged in 100 tablets (10x10 blister package). The recall involves lots N01954 (Exp. 11/30/2025) and N02024 (Exp. 02/28/2026). This medication was distributed nationwide.

The Hazard

The recall addresses CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine, which exceeds the recommended intake limit. This contaminant poses a significant health risk.

Reported Incidents

No specific incidents or injuries related to this recall have been reported. The presence of harmful contaminants warrants immediate action.

What to Do

Consumers and healthcare providers should stop using the recalled tablets immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.

Contact Information

For questions regarding the recall, call Major Pharmaceuticals at 1-800-XXX-XXXX. More information is available at the FDA's website.

Key Facts

  • Recall date: September 12, 2025
  • Quantity recalled: 1,256 blister packs
  • NDC: 0904-7130-61
  • UPC: 00309047130610
  • Expiration dates: 11/30/2025, 02/28/2026

Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product TypeChlorpromazine Hydrochloride Tablets
Sold At
Multiple Retailers

Product Details

Model Numbers
N01954
N02024
UPC Codes
0904-7129
0904-7130
0904-7131
+9 more
Affected States
ALL
Report Date
October 15, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

Related Recalls

HIGH

Acuity Specialty Products Recalls Hand Sanitizer Due to Methanol Risk

Acuity Specialty Products recalled its Wyandotte Sanifect E3 hand sanitizer on September 29, 2025. The recall affects multiple package configurations due to potential methanol contamination. Consumers should stop using the product immediately and contact the company for guidance.

Acuity Specialty Products
cGMP deviations:
Read more
HIGH

AFCO Hand Sanitizer Recalled Due to Methanol Risk

AFCO recalled hand sanitizer on September 29, 2025, due to a risk of methanol contamination. The company failed to conduct required testing on incoming alcohol components. Consumers should stop using the product immediately.

AFCO
cGMP deviations:
Read more