The Recall Desk
HighFDA (Drugs)·D-0171-2023·Announced 2023-02-01

Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution Specification

Ascend Laboratories is recalling 2,628 bottles of Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide due to failed dissolution specification. The tablets may not dissolve properly, preventing proper medication absorption.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II drug recall for a manufacturing defect (failed dissolution) that could prevent medication absorption and reduce drug efficacy. As no illnesses or hospitalizations have been reported, this qualifies as High severity per the rubric for risk-of-harm products without reported injury.

Plain-English summary

Ascend Laboratories, LLC is recalling Metoprolol Succinate Extended-Release Tablets (50 mg) due to a failed dissolution specification. The recall affects 2,628 bottles distributed nationwide and in Puerto Rico under Lot Numbers 21141321 and 21141322 (expiration date 01/31/2023).

The tablets have failed to meet the dissolution specification, which means they may not dissolve at the appropriate rate in the gastrointestinal system. This defect could prevent proper drug absorption and compromise medication efficacy.

Consumers with affected lot numbers should contact their healthcare provider or pharmacist for guidance on this recall.

The recalled product

Product
METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Brand
METOPROLOL SUCCINATE
Manufacturer
Ascend Laboratories, LLC
Category
Drug
Hazard
Affected units
2,628

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 (3)

  • Lot#: 21141321
  • 21141322
  • Exp 01/31/2023.

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 →

Related recalls

Same brand · METOPROLOL SUCCINATE

Same manufacturer · Ascend Laboratories, LLC

See all →

Same hazard · dissolution failure

See all →