Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0393-2022·Announced 2022-02-02

Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution

Ascend Laboratories is recalling Metoprolol Succinate Extended-Release Tablets 25 mg nationwide because the tablets failed to meet dissolution specifications, which may affect how the medication releases in the body.

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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing defect (failed dissolution) affecting drug efficacy rather than safety; the source text states only that the product failed specifications without reporting adverse events or hospitalization.

Plain-English summary

Ascend Laboratories, LLC is recalling Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, distributed nationwide in the United States. The recall affects 9,216 bottles with Lot #21143093 and expiration date of March 2023. The product was manufactured by Alkem Laboratories Ltd. in Mumbai, India.

The tablets failed to meet dissolution specifications. Dissolution is the rate at which the tablet breaks down and releases the active ingredient in the body. When a tablet does not dissolve as intended, it may not deliver the medication properly.

Consumers who have this product should consult their healthcare provider or pharmacist. Do not stop taking the medication without medical guidance, as abruptly stopping metoprolol succinate can be harmful. Your healthcare provider can advise whether your specific supply is affected and recommend next steps.

The recalled product

Product: METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Brand: METOPROLOL SUCCINATE
Manufacturer: Ascend Laboratories, LLC
Category: Drug — Prescription Medication / Cardiovascular
Hazard: failed-dissolution
impaired-drug-release
Affected units: 9,216

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 #: 21143093
Exp. March 2023

Distribution

Distributed nationwide across the United States.

Same brand · METOPROLOL SUCCINATE

Moderate
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Teva metoprolol succinate 25 mg tablets failed dissolution specifications
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Teva metoprolol succinate 200 mg tablets failed dissolution specifications
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Same manufacturer · Ascend Laboratories, LLC

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Same hazard · failed dissolution