RecallRadar

FDA Drug recall D-0169-2023

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai…

On 2023-02-01 the FDA classified a Class II recall of Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai… by Ascend Laboratories, citing failed Dissolution Specification.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0169-2023
ClassificationClass II
Statusterminated
Initiated2023-01-05
Published2023-02-01
Last updated2026-09-13 11:52 UTC
CompanyAscend Laboratories
DistributionUS

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.

Reason

Failed Dissolution Specification

Identifiers

ndc67877-590-30
ndc67877-590-60
ndc67877-590-01
ndc67877-590-05
ndc67877-590-10
ndc67877-591-30
ndc67877-591-60
ndc67877-591-01
ndc67877-591-05
ndc67877-591-10
ndc67877-592-30
ndc67877-592-60
ndc67877-592-01
ndc67877-592-05
ndc67877-592-10
ndc67877-593-30
ndc67877-593-60
ndc67877-593-01
ndc67877-593-05
ndc67877-593-10
code_infoLot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0169-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.