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Class II · ModerateRecall completed

Janumet

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: U015824, Exp. 09/22.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMerck Sharp & Dohme LLC
Brand nameJANUMET
Generic nameSITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Active ingredient(s)METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE
Distributed by / forMerck 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)
NDC0006-0575-02
Show the full FDA record
Full product labelJanumet (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)
Recalling firmMERCK SHARP & DOHME CORP
DistributionNationwide in the USA
Quantity3600 cartons
Recall initiated2022-03-31
Report date2022-04-13
Recall completed2023-08-15
Recall numberD-0746-2022
ClassificationClass II
FDA statusTerminated
Origin on fileWhitehouse Station NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.