REGENECARE HA — Class I drug recall D-0118-2021
Terminated recall by MPM Medical LLC, reported 2020-12-09, distributed nationwide. Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteri
| Recall number | D-0118-2021 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | MPM Medical LLC, Mesquite, TX, United States |
| Recall initiated | 2020-11-17 |
| Classified | 2020-12-07 |
| Reported by FDA | 2020-12-09 |
| Terminated | 2022-09-08 |
| Distributed | Nationwide (US) |
| Quantity | 7,637 tubes |
| Reason classes | microbial contamination, sterility |
| Pathogens | burkholderia |
| NDC | 66977-0107, 66977-0107-03, 66977-0107-04, 66977-0107-05 |
| Lot numbers | 01/21, 41262 |
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.
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-0118-2021. 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.