CLASS II ONGOING Drug recall · Reported 10 Sep 2025 · FDA Enforcement Report
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalled
Amneal Pharmaceuticals is recalling chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, distributed nationwide in the US. The recall was initiated on 18 Aug 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-0616-2025
- FDA event ID
- 97438
- Recalling firm
- Amneal Pharmaceuticals, Bridgewater, NJ
- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Aug 2025
- FDA classified
- 4 Sep 2025
- Reported
- 10 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 18 Aug 2025 | Recall initiated by company | |
| 4 Sep 2025 | Classified by FDA | +17 days |
| 10 Sep 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
chlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100-count bottles, Rx Only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC 69238-1056-1.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Which lots are affected?
Lot AM240617, AM240618, Exp Date 04/30/2027
Where was it sold?
Distributed Nationwide in the 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 97438This product is part of a recall event; the main page for the event is chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide | |
| CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide | |
| CLASS II | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim | Amneal Pharmaceuticals | Packaging Defects | Nationwide | |
| CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
More recalls from Amneal Pharmaceuticals
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Sulfamethoxazole and Trimethoprim Tablets, USP 800mg/160mg recalledSulfamethoxazole And Trimethoprim | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
Other Chlorpromazine recalls
All 28| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 200 mg recalled | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |