Janumet — Class II drug recall D-0746-2022
Terminated recall by MERCK SHARP & DOHME CORP, reported 2022-04-13, distributed nationwide. Presence of foreign substance: Presence of stainless steel particulates in tablets.
| Recall number | D-0746-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MERCK SHARP & DOHME CORP, Whitehouse Station, NJ, United States |
| Recall initiated | 2022-03-31 |
| Classified | 2022-04-05 |
| Reported by FDA | 2022-04-13 |
| Terminated | 2023-08-15 |
| Distributed | Nationwide (US) |
| Quantity | 3,600 cartons |
| Reason classes | specification failure |
| NDC | 00006-0575, 00006-0575-01, 00006-0575-02, 00006-0575-03, 00006-0575-52, 00006-0575-56, 00006-0575-61, 00006-0575-62, 00006-0575-82, 00006-0577, 00006-0577-01, 00006-0577-02, 00006-0577-03, 00006-0577-52, 00006-0577-56, 00006-0577-61, 00006-0577-62, 00006-0577-82 |
| Lot numbers | 09/22, U015824 |
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 for recall
Presence of foreign substance: Presence of stainless steel particulates in tablets.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0746-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.