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 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
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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
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
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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