Medications & Supplements/Prescription Drugs

Metoprolol Succinate Extended-Release Tablets Recalled for Failed Dissolution

Agency Publication Date: January 20, 2023

Summary

Ascend Laboratories, LLC has recalled approximately 58,596 bottles of Metoprolol Succinate Extended-Release Tablets (metoprolol succinate) because the medication failed dissolution testing. This failure means the tablets may not break down and enter the body at the correct rate, which can affect the drug's efficacy. No injuries or adverse incidents have been reported to date regarding these specific lots.

Risk

If the tablets do not dissolve properly, the medication may not provide the intended control over blood pressure or heart rate. This could lead to a lack of therapeutic effect for patients relying on this medication for hypertension or heart conditions.

What You Should Do

This recall affects Metoprolol Succinate Extended-Release Tablets in 25 mg and 50 mg strengths manufactured by Alkem Laboratories and distributed by Ascend Laboratories, LLC.
Identify your medication by checking the bottle label for NDC codes 67877-590-01, 67877-591-01, or 67877-591-05 and lot numbers including 21143094, 21143095, 21143119, 21143121, 21142389, 21142633, 21141321, or 21141322. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Metoprolol Succinate Extended-Release Tablets, USP 25 mg (100 Tablets)

Variants: 25 mg, 100 Tablets per bottle

Lot Numbers:

21143094 (Exp 03/31/2023)

21143095 (Exp 03/31/2023)

21143119 (Exp 03/31/2023)

21143121 (Exp 03/31/2023)

21142389 (Exp 03/31/2023)

NDC:

67877-590-01

Distributed by Ascend Laboratories, LLC

Product: Metoprolol Succinate Extended-Release Tablets, USP 50 mg (100 Tablets)

Variants: 50 mg, 100 Tablets per bottle

Lot Numbers:

21142633 (Exp 03/31/2023)

NDC:

67877-591-01

Distributed by Ascend Laboratories, LLC

Product: Metoprolol Succinate Extended-Release Tablets, USP 50 mg (500 Tablets)

Variants: 50 mg, 500 Tablets per bottle

Lot Numbers:

21141321 (Exp 01/31/2023)

21141322 (Exp 01/31/2023)

NDC:

67877-591-05

Distributed by Ascend Laboratories, LLC

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91442

Status: Resolved

Manufacturer: Ascend Laboratories, LLC

Sold By: pharmacies nationwide

Manufactured In: India, United States

Units Affected: 3 products (49,632 bottles; 6,336 bottles; 2628 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Metoprolol Succinate Extended-Release Tablets in 25 mg and 50 mg strengths manufactured by Alkem Laboratories and distributed by Ascend Laboratories, LLC.

Identify your medication by checking the bottle label for NDC codes 67877-590-01, 67877-591-01, or 67877-591-05 and lot numbers including 21143094, 21143095, 21143119, 21143121, 21142389, 21142633, 21141321, or 21141322. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Metoprolol Succinate Extended-Release Tablets, USP 25 mg (100 Tablets)

Variants: 25 mg, 100 Tablets per bottle

Lot Numbers:

21143094 (Exp 03/31/2023)

21143095 (Exp 03/31/2023)

21143119 (Exp 03/31/2023)

21143121 (Exp 03/31/2023)

21142389 (Exp 03/31/2023)

NDC:

67877-590-01

Distributed by Ascend Laboratories, LLC

Product: Metoprolol Succinate Extended-Release Tablets, USP 50 mg (100 Tablets)

Variants: 50 mg, 100 Tablets per bottle

Lot Numbers:

21142633 (Exp 03/31/2023)

NDC:

67877-591-01

Distributed by Ascend Laboratories, LLC

Product: Metoprolol Succinate Extended-Release Tablets, USP 50 mg (500 Tablets)

Variants: 50 mg, 500 Tablets per bottle

Lot Numbers:

21141321 (Exp 01/31/2023)

21141322 (Exp 01/31/2023)

NDC:

67877-591-05

Distributed by Ascend Laboratories, LLC