CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report

Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalled

American Health Packaging is recalling Metoprolol Succinate Extended-Release Tablets, USP 50 mg, distributed nationwide in the US. The recall was initiated on 20 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023

NDC68001-500, 68001-501, 68001-502, 68001-503

UPC0368001503006, 0368001500005

Quantity recalled6,637 500-count bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0451-2022
FDA event ID: 89377
Recalling firm: American Health Packaging, Columbus, OH
Brand: Metoprolol Succinate
Manufacturer: BluePoint Laboratories
Classification: Class II
Status: Terminated
Recall initiated: 20 Dec 2021
FDA classified: 25 Jan 2022
Reported: 2 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

20 Dec 2021	Recall initiated by company
25 Jan 2022	Classified by FDA	+36 days
2 Feb 2022	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Dissolution Specifications

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications

Which lots are affected?

Lots# 21141983, 21141984 and 21141985, Exp 03/31/2023; Lots# 21142017, 21142018, 21142019, Exp 02/28/2023

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from American Health Packaging

All 60

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS III	Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine	American Health Packaging	Packaging Defects	Nationwide
25 May 2022Drug	CLASS III	Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled	American Health Packaging	Potency & Assay	Nationwide
4 May 2022Drug	CLASS III	Cyanocobalamin Injection, USP, 1000 mcg per mL recalled	American Health Packaging	Potency & Assay	AL
16 Mar 2022Drug	CLASS II	Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride	American Health Packaging	Potency & Assay	Nationwide
27 Oct 2021Drug	CLASS II	GlipiZIDE Extended-Release Tablets, 2.5 mg recalled	American Health Packaging	Potency & Assay	Nationwide

Other Metoprolol recalls

All 40

Reported	Class	Recall	Company	Reason	Where
20 May 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* recalledMetoprolol Succinate	Ascend Laboratories	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 200 mg recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 25 mg bottles recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide
11 Mar 2026Drug	CLASS II	Metoprolol Succinate Extended-Release Tablets, 50 mg bottles recalledMetoprolol Succinate	Teva Pharmaceuticals USA	Potency & Assay	Nationwide