CLASS I Drug recall · Reported 9 Dec 2020 · FDA Enforcement Report
Regenecare HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel recalled
MPM Medical is recalling Regenecare HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel, distributed nationwide in the US. The recall was initiated on 17 Nov 2020 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0118-2021
- FDA event ID
- 86767
- Recalling firm
- MPM Medical, Mesquite, TX
- Brand
- Regenecare Ha
- Manufacturer
- MPM Medical LLC
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Nov 2020
- FDA classified
- 7 Dec 2020
- Reported
- 9 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Pain Medication
Timeline
| 17 Nov 2020 | Recall initiated by company | |
| 7 Dec 2020 | Classified by FDA | +20 days |
| 9 Dec 2020 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Which lots are affected?
Lot: 41262 Exp. 01/21
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Lidocaine recalls
All 119| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Lidocaine Ointment USP, 5% (Generic for Xylocaine) recalled | Preferred Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, Speermint Flavor recalledLidocaine | SUN Pharma /Taro | Potency & Assay | Nationwide |
| Drug | CLASS II | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg recalledXylocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |
| Drug | CLASS III | Lidolog Kit, Kit Contains: Lidocaine HCl Injection recalledLidolog Kit | Asclemed USA | Other | TN |
| Drug | CLASS II | Lidocaine HCl Injection, USP, 2%, 100 mg recalled by Fresenius Kabi USALidocaine | Fresenius Kabi USA | Particulate Matter | Nationwide |