# FDA recall D-0746-2022

> **MERCK SHARP & DOHME CORP** · Class II · drug recall initiated 2022-03-31.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0746-2022
- **Recalling firm:** MERCK SHARP & DOHME CORP
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-31
- **Report date:** 2022-04-13
- **Termination date:** 2023-08-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Whitehouse Station, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0746-2022

## Citation

> AI Analytics. FDA recall D-0746-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0746-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*