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 Risk
Major Pharmaceuticals recalled 2,064 blister packs of Chlorpromazine Hydrochloride Tablets on September 12, 2025. The recall follows the discovery of N-Nitroso Desmethyl Chlorpromazine exceeding safe limits. Consumers must stop using this product immediately and consult healthcare providers for guidance.
Quick Facts at a Glance
- Recall Date
- September 12, 2025
- Hazard Level
- HIGH
- Brands
- Major Pharmaceuticals, Chlorpromazine Hydrochloride
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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 includes Chlorpromazine Hydrochloride Tablets, USP, 25 mg, packaged in blister packs of 50 tablets. The affected lots are N01943 and N02025, with an expiration date of February 28, 2026.
The Hazard
The recall results from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit. This chemical poses a significant health risk to consumers.
Reported Incidents
No specific incidents of injury or illness have been reported in connection with this recall. The contamination risk is classified as high.
What to Do
Stop using the product immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.
Contact Information
For more information, visit the FDA website or contact Major Pharmaceuticals directly. Further details are available at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0009-2026.
Key Facts
- 2064 blister packs recalled
- Chlorpromazine Hydrochloride Tablets, 25 mg
- Risk of N-Nitroso Desmethyl Chlorpromazine contamination
- Stop using immediately
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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
Unknown
Product Details
Model Numbers
N01943
N02025
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