CLASS II Drug recall · Reported 13 Apr 2022 · FDA Enforcement Report
Janumet (sitagliptin and metformin HCl) tablets recalled
Merck Sharp & Dohme is recalling Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, packaged as per, distributed nationwide in the US. The recall was initiated on 31 Mar 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0746-2022
- FDA event ID
- 89893
- Recalling firm
- Merck Sharp & Dohme, Whitehouse Station, NJ
- Brand
- Janumet
- Manufacturer
- Merck Sharp & Dohme LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Mar 2022
- FDA classified
- 5 Apr 2022
- Reported
- 13 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Diabetes Medication
Timeline
| 31 Mar 2022 | Recall initiated by company | |
| 5 Apr 2022 | Classified by FDA | +5 days |
| 13 Apr 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Product as listed by the FDA
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)
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, packaged as per recalled?
Yes. Merck Sharp & Dohme recalled Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, packaged as per on 31 Mar 2022. The recall is Class II and its status is Terminated. Recall number D-0746-2022.
Why was it recalled?
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Which lots are affected?
Lot: U015824, Exp. 09/22.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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