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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- 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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