HIGH
Ketamine Hydrochloride, 50mg/5 mL (10mg/mL), Injection for IV use, 50 mL syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0156-02.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect
HIGH
Major Pharmaceuticals Recalls Chlorpromazine Tablets Over Contaminant Hazard
Major Pharmaceuticals recalled 866 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall follows the detection of N-Nitroso Desmethyl Chlorpromazine above safe limits. The affected products were distributed nationwide and are classified as a Class II hazard.
Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brands
- Major Pharmaceuticals, Chlorpromazine Hydrochloride
- 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 recall affects Chlorpromazine Hydrochloride Tablets, USP, 100 mg, packaged in 100 tablets per blister pack. The recalled lots include N01920, N02023, and N02202, with expiration dates of December 31, 2025, February 28, 2026, and June 30, 2026 respectively. The products were distributed nationwide.
The Hazard
The recall stems from CGMP deviations, specifically the presence of N-Nitroso Desmethyl Chlorpromazine at levels above the recommended intake limit. This contaminant poses potential health risks to consumers.
Reported Incidents
No specific incidents of injury or illness linked to this product have been reported at this time. The hazard level is classified as high due to the potential health implications associated with the contaminant.
What to Do
Consumers and healthcare providers should stop using the recalled product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.
Contact Information
For questions, consumers can reach The Harvard Drug Group LLC at their website or by contacting their customer service.
Key Facts
- 866 blister packs recalled
- Presence of N-Nitroso Desmethyl Chlorpromazine
- Class II recall due to CGMP deviations
- Distributed nationwide
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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
N01920
N02023
N02202
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
Sucralfate Tablets, USP 1 gram, 100 Tablets, (10x10), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC 60687-695-01 - Carton NDC [60687-695-11- Unit Dose]
CGMP Deviations: The recalling firm filed for Chapter 11 on September 30, 2024. As a result, it cannot monitor the quality program and hence cannot assure that products meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess, rendering the products adulterated.
SUCRALFATE
CGMP Deviations:
HIGH
Hydromorphone HCL PF, 10mg/50 mL (0.2mg/mL) in NACL, Injection for IV use, 50 mL Syringe, STAQ Pharma Inc., 14135 E 42nd Ave, Denver, Colorado, NDC 73177-0104-05.
Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect