FDA Drug recall D-0746-2022
Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx…
- FDA Drug
- Class II
- terminated
- Published 2022-04-13
On 2022-04-13 the FDA classified a Class II recall of Janumet (sitagliptin and metformin HCl) tablets, 50 mg/500 mg, 14-count bottle, packaged as 2 bottles per carton , Sample-Not For Sale, Rx… by Merck Sharp And Dohme, citing presence of foreign substance: Presence of stainless steel particulates in tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0746-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-03-31 |
| Published | 2022-04-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Merck Sharp And Dohme |
| Distribution | US |
Product
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)
Reason
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Identifiers
| ndc | 0006-0575-82 |
|---|---|
| ndc | 0006-0575-61 |
| ndc | 0006-0575-62 |
| ndc | 0006-0575-01 |
| ndc | 0006-0575-52 |
| ndc | 0006-0575-56 |
| ndc | 0006-0575-02 |
| ndc | 0006-0575-03 |
| ndc | 0006-0577-61 |
| ndc | 0006-0577-62 |
| ndc | 0006-0577-82 |
| ndc | 0006-0577-01 |
| ndc | 0006-0577-52 |
| ndc | 0006-0577-56 |
| ndc | 0006-0577-02 |
| ndc | 0006-0577-03 |
| code_info | Lot: U015824, Exp. 09/22. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0746-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.