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Class II: temporary or reversible health riskTerminated

Ascend Laboratories Metoprolol Succinate Extended-Release Tablets Recall

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bott…

Ascend Laboratories, LLC · Parsippany, NJ

Risk level
Class II
Reported by FDA
Feb 1, 2023
Recall ID
D-0169-2023
Check your lot numberHow we source this data

Summary

Ascend Laboratories recalled Metoprolol Succinate Extended-Release Tablets starting Jan 5, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0169-2023 on Feb 1, 2023. Reason: Failed Dissolution Specification. Status: Terminated.

Why it was recalled

Failed Dissolution Specification

Product description

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.

Lot numbers, UPCs & expiration codes

Lot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.

Where it was sold

Nationwide and Puerto Rico

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0169-2023
Classification
Class II
Status
Terminated
Recall initiated
Jan 5, 2023
FDA report date
Feb 1, 2023
Quantity
49,632 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Ascend Laboratories, LLC

Original FDA data

Every field from FDA enforcement report D-0169-2023, exactly as published.

Show all FDA fields
City
Parsippany
State
NJ
Status
Terminated
Country
United States
Event ID
91442
Address
339 Jefferson Rd Ste 101
Code information
Lot #s: 21143094, 21143095, 21143119, 21143121, 21142389, Exp 03/31/2023.
Postal code
07054-3707
Report date
Feb 1, 2023
Product type
Drugs
Recall number
D-0169-2023
Classification
Class II
Recalling firm
Ascend Laboratories, LLC
Product quantity
49,632 bottles
Termination date
Aug 15, 2024
Reason for recall
Failed Dissolution Specification
Voluntary / mandated
Voluntary: Firm initiated
Product description
Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.
Distribution pattern
Nationwide and Puerto Rico
Recall initiation date
Jan 5, 2023
Initial firm notification
E-Mail
Center classification date
Jan 20, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0169-2023, published Feb 1, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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