Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ascend Laboratories, LLC, originally initiated on 01-05-2023 for the product Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01. The product was recalled due to failed dissolution specification. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0169-2023 | 01-05-2023 | 02-01-2023 | Class II | 49,632 bottles | Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01. | Failed Dissolution Specification | Terminated |
| D-0170-2023 | 01-05-2023 | 02-01-2023 | Class II | 6,336 bottles | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01. | Failed Dissolution Specification | Terminated |
| D-0171-2023 | 01-05-2023 | 02-01-2023 | Class II | 2628 bottles | Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05. | Failed Dissolution Specification | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 67877-590 | Metoprolol Succinate | Metoprolol Succinate Er Tablets | Tablet, Film Coated, Extended Release | Oral | Ascend Laboratories, Llc | Human Prescription Drug |
| 67877-591 | Metoprolol Succinate | Metoprolol Succinate Er Tablets | Tablet, Film Coated, Extended Release | Oral | Ascend Laboratories, Llc | Human Prescription Drug |
| 67877-592 | Metoprolol Succinate | Metoprolol Succinate Er Tablets | Tablet, Film Coated, Extended Release | Oral | Ascend Laboratories, Llc | Human Prescription Drug |
| 67877-593 | Metoprolol Succinate | Metoprolol Succinate Er Tablets | Tablet, Film Coated, Extended Release | Oral | Ascend Laboratories, Llc | Human Prescription Drug |
