Merck Sharp & Dohme Corp is recalling a specific lot of Janumet (sitagliptin and metformin HCl) tablets because they may contain stainless steel particulates. The affected product is the 50 mg/500 mg strength, packaged as two 14-count bottles per carton. The recall covers 3,600 cartons distributed nationwide in the USA. Read more at govinfonow.com/recall/35032-janumet-recall-stainless-steel-particulates-in-tablets.
“Janumet Recall: Stainless Steel Particulates in Tablets.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35032-janumet-recall-stainless-steel-particulates-in-tablets. Based on FDA recall #D-0746-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0746-2022%22&limit=1).
Merck Sharp & Dohme Corp. recalled Janumet tablets due to stainless steel particulates, the FDA said on March 31, 2022. The voluntary Class II recall involved 3,600 cartons distributed nationwide.
How to tell if you have it
Brand: Janumet
Product: Janumet Tablets 50mg/500mg
NDC Bottle: 0006-0575-02
NDC Carton: 0006-0575-03
Lot: U015824
Expiration: 09/22
The hazard
The recall addresses the presence of stainless steel particulates in the tablets. The FDA classified the hazard as Class II.
Context
GovInfoNow's records show Merck Sharp & Dohme Corp. has one other recall on record since October 19, 2021: a Cubicin injection recall for glass particles on that date. Other recent recalls of similar products include a Merck Noxafil Powdermix recall for metal particulates (December 12, 2025), a Sunny Pharmtech Cyclophosphamide Injection recall for stainless steel particulate risk (July 17, 2026), and a Guardian Drug Goodsense Ultra Strength Antacid Tablets recall for metallic particles hazard (May 28, 2026).
How to tell if you have this one
Check your bottle for the NDC number 0006-0575-02 (Bottle) and 0006-0575-03 (Carton). Verify the Lot number is U015824 and the expiration date is 09/22. The product was manufactured by Patheon Puerto Rico, Inc.
Brand
Janumet
Category
Drug
Based on the official FDA remedy
What to do — step by step
Stop taking the medication
Do not consume tablets from the recalled lot due to the risk of ingesting stainless steel particulates.
Contact your healthcare provider
Speak with your doctor or pharmacist about alternative treatments since no specific remedy is listed in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 16 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0746-2022 (March 31, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0746-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.