The Recall Desk
ModerateFDA (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.

What this means for you

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

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.

Related recalls

Same brand · METOPROLOL SUCCINATE

Same category