# FDA recall D-0118-2021

> **MPM Medical LLC** · Class I · drug recall initiated 2020-11-17.

## Product

REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g),  Manufactured For: MPM Medical Mesquite, TX 75149. NDC 66977-107-03

## Reason for recall

Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0118-2021
- **Recalling firm:** MPM Medical LLC
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-11-17
- **Report date:** 2020-12-09
- **Termination date:** 2022-09-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mesquite, TX, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0118-2021

## Citation

> AI Analytics. FDA recall D-0118-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0118-2021. Source: US FDA. Licensed CC0.

---

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