[pending] CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0009-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
The recalled product
- Product
- CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE HYDROCHLORIDE)
- Brand
- CHLORPROMAZINE HYDROCHLORIDE
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots N01943 and Lot N02025
- exp. date 02/28/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CHLORPROMAZINE HYDROCHLORIDE
- ModerateChlorpromazine Hydrochloride Tablets Recalled Due to Impurity
FDA (Drugs) · 2025-04-23
- SevereChlorpromazine Hydrochloride Tablets Recalled Due to Impurity
FDA (Drugs) · 2025-04-16
- ModeratePrescription Antipsychotic Drug Recalled for Manufacturing Impurity
FDA (Drugs) · 2025-04-09
- HighPrescription chlorpromazine tablets recalled due to manufacturing quality defect
FDA (Drugs) · 2025-01-01
- HighChlorpromazine Hydrochloride tablets recalled for manufacturing impurity excess
FDA (Drugs) · 2025-01-01
Same category
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22