CLASS II ONGOING Drug recall · Reported 24 Sep 2025 · FDA Enforcement Report
chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks recalled
Amerisource Health Services is recalling chlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 blisterpacks, distributed nationwide in the US. The recall was initiated on 27 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-0648-2025
- FDA event ID
- 97533
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Manufacturer
- American Health Packaging
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Aug 2025
- FDA classified
- 15 Sep 2025
- Reported
- 24 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
Timeline
| 27 Aug 2025 | Recall initiated by company | |
| 15 Sep 2025 | Classified by FDA | +19 days |
| 24 Sep 2025 | Published in enforcement report | +9 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 at the manufacturing site, 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, 50 mg, 100 (10x10) blisterpacks, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. 50 Tablet Carton NDC#: 60687-441-01 (Individual Dose NDC: 60687-441-11)
Where it was 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 at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Which lots are affected?
Lot: 1022159, exp 12/31/2026; 1023299, exp 03/31/2027; 1024057, Exp 04/30/2027
Where was it sold?
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
3 other products · FDA event 97533This 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 | Amerisource Health Services | Packaging Defects | Nationwide | |
| CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 100 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide | |
| CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 25 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
More recalls from Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Chlorpromazine recalls
All 28| 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, 200 mg recalledChlorpromazine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Chlorpromazine Hydrochloride Tablets, USP, 10 mg recalledChlorpromazine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Chlorpromazine Hydrochloride Tablets, USP, 200 mg recalledChlorpromazine Hydrochloride | Zydus Pharmaceuticals | Nitrosamine Impurity | Nationwide |