CLASS II Drug recall · Reported 25 May 2016 · FDA Enforcement Report
Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%) patches recalled
Tmig is recalling Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%) patches per, distributed nationwide in the US. The recall was initiated on 23 Mar 2016 and the FDA has classified it as Class II.
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-0855-2016
- FDA event ID
- 73571
- Recalling firm
- Tmig, Marietta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Mar 2016
- FDA classified
- 17 May 2016
- Reported
- 25 May 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Hidden Drug Ingredients
- Drug class
- Creams, Ointments & Gels
Timeline
| 23 Mar 2016 | Recall initiated by company | |
| 17 May 2016 | Classified by FDA | +55 days |
| 25 May 2016 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Products marketed as supplements sometimes contain undeclared prescription drug ingredients such as sildenafil or sibutramine. These can interact dangerously with other medicines.
Product as listed by the FDA
Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Which lots are affected?
All lots
Where was it sold?
Nationwide
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.