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 Hydrochloride Tablets Due to Hazardous Chemical
Major Pharmaceuticals recalled 506 blister packs of Chlorpromazine Hydrochloride tablets on September 12, 2025. The recall stems from CGMP deviations due to the presence of N-Nitroso Desmethyl Chlorpromazine above safe limits. Consumers should stop using the product immediately and consult healthcare providers.
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 recalled product is Chlorpromazine Hydrochloride Tablets, USP, 50 mg, packaged in 100 tablet blister packs. The affected lots are N02009 and N02026 with an expiration date of February 28, 2026. The product was distributed nationwide.
The Hazard
The recall was initiated due to CGMP deviations. N-Nitroso Desmethyl Chlorpromazine levels exceeded the recommended intake limit.
Reported Incidents
No specific incidents or injuries have been reported in relation to the recalled product. The potential risk remains high due to the hazardous chemical present.
What to Do
Stop using the recalled tablets immediately. Contact The Harvard Drug Group LLC or your healthcare provider for further guidance.
Contact Information
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0011-2026 or call The Harvard Drug Group LLC.
Key Facts
- 506 blister packs recalled
- Presence of hazardous chemical
- Stop using immediately
- Contact healthcare provider for guidance
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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
N02009
N02026
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:
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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