FDA Drug recall D-0118-2021
REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149
- FDA Drug
- Class I
- terminated
- Published 2020-12-09
On 2020-12-09 the FDA classified a Class I recall of REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured For: MPM Medical Mesquite, TX 75149 by Mpm Medical, citing microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0118-2021 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2020-11-17 |
| Published | 2020-12-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mpm Medical |
| Distribution | US |
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
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Identifiers
| ndc | 66977-107-03 |
|---|---|
| ndc | 66977-107-04 |
| ndc | 66977-107-05 |
| code_info | Lot: 41262 Exp. 01/21 |
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-0118-2021%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.