CLASS II ONGOING Drug recall · Reported 23 Apr 2025 · FDA Enforcement Report
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg recalled
The Harvard Drug Group is recalling ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 14 Apr 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0366-2025
- FDA event ID
- 96679
- Recalling firm
- The Harvard Drug Group, La Vergne, TN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Apr 2025
- FDA classified
- 16 Apr 2025
- Reported
- 23 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 14 Apr 2025 | Recall initiated by company | |
| 16 Apr 2025 | Classified by FDA | +2 days |
| 23 Apr 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7129-61
Where it was distributed
Nationwide USA
Questions about this recall
Is ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg recalled?
Yes. The Harvard Drug Group recalled ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg on 14 Apr 2025. The recall is Class II and its status is Ongoing. Recall number D-0366-2025.
Why was it recalled?
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Which lots are affected?
Lot#: N02114, Exp 12/31/2025
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from The Harvard Drug Group
All 79| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Carton Label: Major, Methylergonovine Maleate Tablets recalledMethylergonovine Maleate | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Omega-3-Acid, Ethyl Esters, Capsules recalled by The Harvard Drug GroupOmega-3-acid Ethyl Esters | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Memantine Hydrochloride Extended-Release, Capsules, 7 mg recalledMemantine Hydrochloride | The Harvard Drug Group | Potency & Assay | Nationwide |
| Drug | CLASS II | Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride | The Harvard Drug Group | Packaging Defects | Nationwide |
| Drug | CLASS II | Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin | The Harvard Drug Group | Potency & Assay | Nationwide |
Other Chlorpromazine recalls
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride | Zydus Pharmaceuticals (USA) | Nitrosamine Impurity | Nationwide |