RecallRadar

FDA Drug recall D-0451-2022

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400…

On 2022-02-02 the FDA classified a Class II recall of Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400… by American Health Packaging, citing failed Dissolution Specifications.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0451-2022
ClassificationClass II
Statusterminated
Initiated2021-12-20
Published2022-02-02
Last updated2026-09-13 11:52 UTC
CompanyAmerican Health Packaging
DistributionUS

Product

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03

Reason

Failed Dissolution Specifications

Identifiers

ndc68001-500-00
ndc68001-500-03
ndc68001-500-08
ndc68001-501-00
ndc68001-501-03
ndc68001-501-08
ndc68001-502-00
ndc68001-502-03
ndc68001-502-08
ndc68001-503-00
code_infoLots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023

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-0451-2022%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.