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 1,394 blister packs of Chlorpromazine Hydrochloride Tablets due to contamination concerns. The recall occurred on September 12, 2025, after the FDA found N-Nitroso Desmethyl Chlorpromazine above acceptable limits. Consumers should stop using these tablets and seek guidance from healthcare providers.
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 recall includes Chlorpromazine Hydrochloride Tablets, USP, 200 mg, packaged in 100 tablets per blister pack. The affected lots include N01928, N02008, and N02071, with expiration dates ranging from February 28, 2026, to March 21, 2026.
The Hazard
The product contains N-Nitroso Desmethyl Chlorpromazine, which exceeds the recommended intake limit. This contamination poses a serious health risk to consumers.
Reported Incidents
No specific incidents or injuries have been reported related to this contamination at this time. However, the presence of the hazardous substance necessitates immediate action.
What to Do
Stop using the product immediately. Contact Major Pharmaceuticals or your healthcare provider for guidance regarding this recall.
Contact Information
For more information, call The Harvard Drug Group LLC at 1-800-XXXX-XXXX or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0013-2026.
Key Facts
- Recall date: September 12, 2025
- Quantity recalled: 1,394 blister packs
- Hazard: N-Nitroso Desmethyl Chlorpromazine contamination
- FDA classification: Class II
- Stop using the product 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
Multiple Retailers
Product Details
Model Numbers
N01928
N02008
N02071
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
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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.
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Labeling: Incorrect or Missing Lot and/or Exp Date
STAQ Pharma
Labeling: Incorrect