Medications & Supplements/Prescription Drugs

Janumet Diabetes Tablets Recalled for Potential Metal Particulates

Agency Publication Date: April 5, 2022

Summary

Merck Sharp & Dohme Corp has voluntarily recalled 3,600 cartons of Janumet (sitagliptin and metformin HCl) tablets because they may contain small stainless steel metal particles. Janumet is a prescription medication used to manage blood sugar levels in adults with type 2 diabetes. This specific recall affects sample bottles provided to healthcare providers rather than standard retail packages. No injuries or adverse incidents have been reported to date, but the presence of foreign material in the medication poses a potential health risk.

Risk

Ingesting tablets contaminated with metal particulates could potentially cause irritation or injury to the digestive tract. While no injuries have been reported, consumers should stop using the affected samples to avoid the risk of internal injury.

What You Should Do

This recall affects Janumet (sitagliptin and metformin HCl) 50 mg/500 mg tablets in 14-count sample bottles (NDC 0006-0575-02) and two-bottle cartons (NDC 0006-0575-03).
Identify affected product by looking for lot number U015824 and an expiration date of September 2022 (09/22) printed on the bottle or carton label.
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.
Contact Merck Sharp & Dohme Corp directly for further instructions regarding this recall.
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: Janumet (sitagliptin and metformin HCl) tablets (50 mg/500 mg)

Variants: 50 mg/500 mg strength, 14-count bottle, Sample-Not For Sale, 2 bottles per carton

Lot Numbers:

U015824 (Exp. 09/22)

NDC:

0006-0575-02

0006-0575-03

Manufactured by Patheon Puerto Rico, Inc. for Merck Sharp & Dohme Corp.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89893

Status: Resolved

Manufacturer: MERCK SHARP & DOHME CORP

Sold By: Physician offices; Healthcare providers; Pharmacies

Manufactured In: United States, Puerto Rico

Units Affected: 3600 cartons

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 Janumet (sitagliptin and metformin HCl) 50 mg/500 mg tablets in 14-count sample bottles (NDC 0006-0575-02) and two-bottle cartons (NDC 0006-0575-03).

Identify affected product by looking for lot number U015824 and an expiration date of September 2022 (09/22) printed on the bottle or carton label.

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.

Contact Merck Sharp & Dohme Corp directly for further instructions regarding this recall.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.