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.

FDA recall notice · announced February 1, 2023 · Ascend Laboratories

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

Reason for recall

Failed Dissolution Specification

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.
Quantity: 49,632 bottles
Status: Terminated
Products in this recall event:
- 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, (D-0170-2023)
- 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, (D-0171-2023)
- 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, (D-0169-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.