Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0170-2023·Announced 2023-02-01

Metoprolol Succinate Tablets Recalled for Failed Dissolution Specification

Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall of a cardiac medication for failed dissolution specification. No illnesses or injuries have been reported. This is a precautionary quality-control recall, falling under the category of voluntary precautionary recalls.

Plain-English summary

Ascend Laboratories, LLC is recalling Metoprolol Succinate Extended-Release Tablets, 50 mg (Rx Only). The affected product is NDC 67877-591-01 with 100 tablets per bottle, manufactured by Alkem Laboratories Ltd. in Mumbai, India. A total of 6,336 bottles with Lot #21142633 (expiration 03/31/2023) have been recalled.

The tablets were distributed nationwide and in Puerto Rico. The recall is due to failed dissolution specification on these tablets.

Patients currently taking this medication should consult their healthcare provider or pharmacist regarding their treatment options. Do not stop taking cardiac medications without first speaking with a healthcare provider.

This is an FDA Class II recall.

The recalled product

Product: METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Brand: METOPROLOL SUCCINATE
Manufacturer: Ascend Laboratories, LLC
Category: Drug — Cardiovascular
Hazard: dissolution-failure
quality-defect
Affected units: 6,336

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot #: 21142633
Exp 03/31/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Ascend Laboratories, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same brand · METOPROLOL SUCCINATE

Moderate
Metoprolol Succinate Extended-Release Tablets Recalled Due to Failed Dissolution
FDA (Drugs) · 2026-05-20
High
Teva metoprolol succinate 100 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
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Teva metoprolol succinate 50 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
High
Teva metoprolol succinate 25 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11
High
Teva metoprolol succinate 200 mg tablets failed dissolution specifications
FDA (Drugs) · 2026-03-11

Same manufacturer · Ascend Laboratories, LLC

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Same hazard · dissolution failure