FDA Drug · D-0746-2022

Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx Only, Manufactured for Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08889, USA, by Patheon Puerto Rico, Inc. Manati, Puerto Rico, 00674 Bottle (NDC 0006-0575-02), Carton (NDC 0006-0575-03)

Class II · Terminated

Presence of foreign substance: Presence of stainless steel particulates in tablets.

Affected lots / codes — check yours against thisLot: U015824, Exp. 09/22.

Recalling firm: MERCK SHARP & DOHME CORP, Whitehouse Station, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Terminated
Quantity: 3600 cartons
Distribution: Nationwide in the USA
Recall initiated: March 31, 2022
Classified: April 5, 2022
Terminated: August 15, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0746-2022%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

See every recall for this brand: Is JANUMET recalled? →

Check this brand across all 8 databases →