The Recall Desk
HighFDA (Drugs)·D-0746-2022·Announced 2022-04-13

Diabetes Drug Janumet Recalled Due to Stainless Steel Contamination

Merck is recalling 3,600 cartons of Janumet (sitagliptin/metformin HCl) tablets nationwide due to the presence of stainless steel particulates in the tablets.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a foreign substance (stainless steel particulates) in an oral medication. Per the rubric, risk-of-harm products without reported injuries are rated High.

Plain-English summary

Merck Sharp & Dohme Corp. is recalling 3,600 cartons of Janumet (sitagliptin and metformin hydrochloride), 50 mg/500 mg tablets, distributed nationwide in the United States. The affected product is packaged as sample tablets not for sale, in 14-count bottles with 2 bottles per carton. The affected lot number is U015824, with an expiration date of September 2022.

The recall was initiated due to the presence of stainless steel particulates in the tablets. This is a Class II recall by the FDA.

The recalled product

Product
JANUMET (SITAGLIPTIN AND METFORMIN HYDROCHLORIDE)
Brand
JANUMET
Manufacturer
MERCK SHARP & DOHME CORP
Category
Drug — Oral Tablet / Contamination
Hazard
Affected units
3,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot: U015824
  • Exp. 09/22.

UPCs (2)

  • 0300060575617
  • 0300060577611

Distribution

Distributed nationwide across the United States.

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