TMIG Recalls Renovo Patches: Unapproved Drug & Subpotent Lots
TMIG Inc recalls Renovo Patches (Capsaicin/Menthol) distributed nationwide. The drug is unapproved and some lots are subpotent. No remedy details provided.
Use caution until it’s fixed
Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent.
Contact the company
What happened, in plain English
TMIG Inc is recalling Renovo Patches, a prescription topical patch containing capsaicin and menthol, because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, three specific lots of this product were found to be subpotent, meaning they may not deliver the intended dosage. The recall covers all lots of the 3-count cartons distributed nationwide. Read more at govinfonow.com/recall/43104-tmig-recalls-renovo-patches-unapproved-drug-subpotent-lots.
Source Summary by GovInfoNow · govinfonow.com/recall/43104-tmig-recalls-renovo-patches-unapproved-drug-subpotent-lots · Updated October 11, 2026 · FDA enforcement record: FDA #D-0855-2016
Cite this page
“TMIG Recalls Renovo Patches: Unapproved Drug & Subpotent Lots.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43104-tmig-recalls-renovo-patches-unapproved-drug-subpotent-lots. Based on FDA recall #D-0855-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0855-2016%22&limit=1).
Why it’s dangerous
The primary danger is that the drug was marketed without FDA approval, meaning its safety and efficacy have not been fully verified through the standard regulatory process. Furthermore, three lots were identified as subpotent, which means users might receive less medication than labeled, potentially leading to inadequate pain relief or treatment failure.
Who’s affected
Individuals who have been prescribed or purchased Renovo Patches from TMIG Inc between the relevant distribution period. Patients relying on this medication for pain management may be affected by the lack of regulatory approval and potential potency issues.
How to tell if you have this one
Look for Renovo Patches distributed by TMIG Inc in Marietta, GA. The product contains Capsaicin 0.0375% and Menthol USP 5.00%, comes in 3-count cartons, and carries NDC: 69176-025-03. The recall applies to all lots of this specific product.
- Brand
TMIG Inc- Category
Drug
What to do — step by step
Check Your Product Details
Verify if you have Renovo Patches distributed by TMIG Inc with NDC: 69176-025-03 in 3-count cartons.
Consult Your Healthcare Provider
Speak with your doctor or pharmacist about the recall and discuss alternative treatment options if necessary.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 20 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0855-2016 (March 23, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0855-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.