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Drug FDA Class II Ongoing Failed specifications

Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.

Ascend Laboratories, LLC Published May 20, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Ascend Laboratories, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Dissolution Specifications

Hazards

Failed Dissolution · primary

Affected products (1)

Ascend Laboratories, LLC, Metoprolol Succinate Extended-Release Tablets, USP, 25 mg* Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-590-01.

METOPROLOL SUCCINATE · 17,304 100-count bottles

NDC: 67877-590, 67877-591, 67877-592, 67877-593, 67877-590-30, 67877-590-60, 67877-590-01, 67877-590-05, 67877-590-10, 67877-591-30, 67877-591-60, 67877-591-01, 67877-591-05, 67877-591-10, 67877-592-30, 67877-592-60, 67877-592-01, 67877-592-05, 67877-592-10, 67877-593-30, 67877-593-60, 67877-593-01, 67877-593-05, 67877-593-10
Lot codes: 25140859
Code info: Lot # 25140859; Exp. Date: Jan 2027

Affected areas

Nationwide

Timeline

  1. Initiated
    Apr 27, 2026
  2. Published
    May 20, 2026
Recall number
D-0547-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.