REGENECARE HA (MPM Medical) – Microbial Contamination (2020)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
MPM Medical LLC
Lot Codes / Batch Numbers
Lot: 41262 Exp. 01/21
Products Sold
Lot: 41262 Exp. 01/21
MPM Medical LLC is recalling REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, Net Wt. 3 oz. (85 g), Manufactured Fo due to Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026