Multi event Drug Recall Enforcement Report Class II voluntary initiated by AvKARE, originally initiated on 08-25-2025 for the product chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15 The product was recalled due to presence of a foreign substance.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0643-2025 | 08-25-2025 | 09-17-2025 | Class II | 1512 cartons | chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15 | Presence of a foreign substance. | Ongoing |
| D-0644-2025 | 08-25-2025 | 09-17-2025 | Class II | 2003 cartons | chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15 | Presence of a foreign substance. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 50268-162 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Avpak | Human Prescription Drug |
| 50268-163 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Avpak | Human Prescription Drug |
| 50268-164 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Avpak | Human Prescription Drug |
| 50268-165 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Avpak | Human Prescription Drug |
| 50268-166 | Chlorpromazine Hydrochloride | Chlorpromazine Hydrochloride | Tablet, Film Coated | Oral | Avpak | Human Prescription Drug |
