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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Topical Products

MPM Medical LLC: Regenecare HA Topical Hydrogel Recalled for Bacterial Contamination

Agency Publication Date: December 1, 2020
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Summary

MPM Medical LLC has recalled 7,637 tubes of Regenecare HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel because the product was found to be contaminated with Burkholderia cepecia bacteria. This 3 oz. (85 g) topical gel is used to provide temporary relief of pain and itching. Consumers who have the affected lot number 41262 should immediately stop using the product and contact their healthcare provider or pharmacist for guidance.

Risk

The product is contaminated with Burkholderia cepecia, a bacteria that can cause serious infections, particularly in individuals with weakened immune systems or underlying lung conditions like cystic fibrosis. Use of a contaminated topical product on damaged skin or mucous membranes could lead to localized or systemic infections.

What You Should Do

  1. Locate your 3 oz. (85 g) tube of Regenecare HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel.
  2. Check the packaging for NDC 66977-107-03 and Lot number 41262 with an expiration date of 01/21 (January 2021).
  3. Stop using any product identified as part of this recalled lot immediately.
  4. Contact your healthcare provider or pharmacist for guidance regarding any health concerns or symptoms you may be experiencing after using this product.
  5. Return any unused product to the place of purchase for a full refund and contact MPM Medical LLC at 1801 Big Town Blvd Ste 300, Mesquite, Texas, 75149 for further instructions.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: REGENECARE HA (Lidocaine HCL 2%) Topical Anesthetic Hydrogel (3 oz. / 85 g)
Model:
NDC 66977-107-03
Recall #: D-0118-2021
Lot Numbers:
41262 (Exp. 01/21)
Date Ranges: Expiration Date: 01/21

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 86767
Status: Resolved
Manufacturer: MPM Medical LLC
Manufactured In: United States
Units Affected: 7,637 tubes
Distributed To: Nationwide
Agency Last Updated: December 7, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.