Medications & Supplements/Prescription Drugs

Metoprolol Tartrate Tablets Recalled for Elevated Nitrosamine Levels

Agency Publication Date: August 12, 2025

Summary

Westminster Pharmaceuticals LLC is recalling 21,128 bottles of Metoprolol Tartrate Tablets, USP (50 mg and 100 mg strengths) due to the presence of N-nitroso-metoprolol. This chemical is a type of nitrosamine that was found at levels higher than the established Acceptable Daily Intake limit. The affected products include 16,672 bottles of the 50 mg strength and 4,456 bottles of the 100 mg strength, all packaged in 1000-count bottles for prescription use. Consumers should speak with their doctor or pharmacist about alternative treatment options before stopping their medication.

Risk

N-nitroso-metoprolol is a nitrosamine compound, which is classified as a potential human carcinogen. Long-term exposure to these impurities above acceptable levels may increase the risk of cancer.

What You Should Do

This recall affects Metoprolol Tartrate Tablets, USP (50 mg and 100 mg strengths) sold in 1000-count bottles under the Westminster Pharmaceuticals brand.
To identify if your medication is affected, check the National Drug Code (NDC) and batch/lot numbers printed on the bottle. The 50 mg tablets have NDC 69367-354-10, and the 100 mg tablets have NDC 69367-355-10. 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 Tartrate Tablets, USP (50 mg)by Westminster Pharmaceuticals

Variants: 50 mg, 1000 Tablets

Lot Numbers:

R55230021 (Exp 9/30/25)

R55230031 (Exp 9/30/25)

R55230041 (Exp 9/30/25)

R55230051 (Exp 10/31/2025)

R55230061 (Exp 10/31/2025)

R55230071 (Exp 10/31/2025)

R55230081 (Exp 10/31/2025)

R55230091 (Exp 10/31/2025)

R55230101 (Exp 10/31/2025)

R55230111 (Exp 10/31/2025)

R55230121 (Exp 10/31/2025)

R55230131 (Exp 10/31/2025)

R55230141 (Exp 10/31/2025)

R55230151 (Exp 11/30/25)

R55240011 (Exp 12/31/25)

R55240021 (Exp 6/30/26)

R55240031 (Exp 6/30/26)

R55240041 (Exp 6/30/26)

R55240051 (Exp 6/30/26)

R55240061 (Exp 6/30/26)

R55240071 (Exp 7/31/26)

R55240081 (Exp 7/31/26)

R55240091 (Exp 7/31/26)

R55240101 (Exp 7/31/26)

R55240111 (Exp 7/31/26)

R55240121 (Exp 7/31/26)

NDC:

69367-354-10

Product: Metoprolol Tartrate Tablets, USP (100 mg)by Westminster Pharmaceuticals

Variants: 100 mg, 1000 Tablets

Lot Numbers:

R56240011 (Exp 2/28/26)

R56240021 (Exp 3/31/26)

R56240031 (Exp 3/31/26)

R56240041 (Exp 4/30/26)

R56240051 (Exp 4/30/26)

R56240061 (Exp 4/30/26)

R56240071 (Exp 7/31/26)

NDC:

69367-355-10

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97395

Status: Active

Manufacturer: Westminster Pharmaceuticals LLC

Sold By: Pharmacies; Healthcare Providers

Manufactured In: Bangladesh

Units Affected: 2 products (16,672 1000-count bottles; 4,456 1000-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 Tartrate Tablets, USP (50 mg and 100 mg strengths) sold in 1000-count bottles under the Westminster Pharmaceuticals brand.

To identify if your medication is affected, check the National Drug Code (NDC) and batch/lot numbers printed on the bottle. The 50 mg tablets have NDC 69367-354-10, and the 100 mg tablets have NDC 69367-355-10. 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 Tartrate Tablets, USP (50 mg)by Westminster Pharmaceuticals

Variants: 50 mg, 1000 Tablets

Lot Numbers:

R55230021 (Exp 9/30/25)

R55230031 (Exp 9/30/25)

R55230041 (Exp 9/30/25)

R55230051 (Exp 10/31/2025)

R55230061 (Exp 10/31/2025)

R55230071 (Exp 10/31/2025)

R55230081 (Exp 10/31/2025)

R55230091 (Exp 10/31/2025)

R55230101 (Exp 10/31/2025)

R55230111 (Exp 10/31/2025)

R55230121 (Exp 10/31/2025)

R55230131 (Exp 10/31/2025)

R55230141 (Exp 10/31/2025)

R55230151 (Exp 11/30/25)

R55240011 (Exp 12/31/25)

R55240021 (Exp 6/30/26)

R55240031 (Exp 6/30/26)

R55240041 (Exp 6/30/26)

R55240051 (Exp 6/30/26)

R55240061 (Exp 6/30/26)

R55240071 (Exp 7/31/26)

R55240081 (Exp 7/31/26)

R55240091 (Exp 7/31/26)

R55240101 (Exp 7/31/26)

R55240111 (Exp 7/31/26)

R55240121 (Exp 7/31/26)

NDC:

69367-354-10

Product: Metoprolol Tartrate Tablets, USP (100 mg)by Westminster Pharmaceuticals

Variants: 100 mg, 1000 Tablets

Lot Numbers:

R56240011 (Exp 2/28/26)

R56240021 (Exp 3/31/26)

R56240031 (Exp 3/31/26)

R56240041 (Exp 4/30/26)

R56240051 (Exp 4/30/26)

R56240061 (Exp 4/30/26)

R56240071 (Exp 7/31/26)

NDC:

69367-355-10