Medications & Supplements/Prescription Drugs

Metoprolol Succinate ER Tablets Recalled for Failed Dissolution

Agency Publication Date: January 25, 2022

Summary

American Health Packaging has recalled 6,637 bottles of Metoprolol Succinate Extended-Release Tablets (50 mg), a medication used to treat high blood pressure and heart conditions. The recall was initiated because the tablets failed dissolution testing, meaning they may not release the medication into the body at the correct rate. No injuries or adverse events have been reported in connection with this recall.

Risk

If the medication does not dissolve properly, it may result in the patient receiving too much or too little of the drug at one time. This could lead to poorly controlled blood pressure or an increased risk of heart-related complications.

What You Should Do

This recall affects Metoprolol Succinate Extended-Release Tablets, USP 50 mg, sold in 500-count bottles (NDC 68001-501-03) and manufactured by Alkem Laboratories Ltd.
Check the bottle for lot numbers 21141983, 21141984, 21141985, 21142017, 21142018, or 21142019. 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) or visit www.fda.gov/safety/recalls for additional information.

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 (500-count bottle)

Variants: 50 mg, Extended-Release, Tablet

Lot Numbers:

21141983 (Exp 03/31/2023)

21141984 (Exp 03/31/2023)

21141985 (Exp 03/31/2023)

21142017 (Exp 02/28/2023)

21142018 (Exp 02/28/2023)

21142019 (Exp 02/28/2023)

NDC:

68001-501-03

Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. Recall #: D-0451-2022.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89377

Status: Resolved

Manufacturer: American Health Packaging

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 6,637 500-count 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, USP 50 mg, sold in 500-count bottles (NDC 68001-501-03) and manufactured by Alkem Laboratories Ltd.

Check the bottle for lot numbers 21141983, 21141984, 21141985, 21142017, 21142018, or 21142019. 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) or visit www.fda.gov/safety/recalls for additional information.

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 (500-count bottle)

Variants: 50 mg, Extended-Release, Tablet

Lot Numbers:

21141983 (Exp 03/31/2023)

21141984 (Exp 03/31/2023)

21141985 (Exp 03/31/2023)

21142017 (Exp 02/28/2023)

21142018 (Exp 02/28/2023)

21142019 (Exp 02/28/2023)

NDC:

68001-501-03

Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. Recall #: D-0451-2022.