Bonita Pharmaceuticals Recalls Menthocin Patches Due to Unapproved Status
Bonita Pharmaceuticals recalls Menthocin Patches marketed without an approved NDA/ANDA. Check lot numbers and expiration dates for affected units.
Recall notice
Marketed without an approved NDA/ANDA
Contact the company
What happened, in plain English
Bonita Pharmaceuticals, LLC is recalling Menthocin Patch with Lidocaine-Strong because it was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). The recall affects 3,308 boxes distributed nationwide. This regulatory issue means the product's safety and efficacy have not been formally reviewed by the FDA for this specific marketing status. Read more at govinfonow.com/recall/43205-bonita-pharmaceuticals-recalls-menthocin-patches-due-to-unapproved-status.
Source Summary by GovInfoNow · govinfonow.com/recall/43205-bonita-pharmaceuticals-recalls-menthocin-patches-due-to-unapproved-status · Updated October 11, 2026 · FDA enforcement record: FDA #D-0665-2016
Cite this page
“Bonita Pharmaceuticals Recalls Menthocin Patches Due to Unapproved Status.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43205-bonita-pharmaceuticals-recalls-menthocin-patches-due-to-unapproved-status. Based on FDA recall #D-0665-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0665-2016%22&limit=1).
Why it’s dangerous
The primary hazard identified is regulatory: the drug was marketed without the required FDA approval (NDA/ANDA). The record does not describe any specific physical injury mechanism, such as chemical burns or allergic reactions, associated with the patch itself.
Who’s affected
Consumers who purchased Menthocin Patches with Lidocaine-Strong from pharmacies or retailers across the United States. The record does not specify which patient groups are most at risk, only that the product is prescription-only (RX Only).
How to tell if you have this one
Look for Menthocin Patch with Lidocaine-Strong in a box containing 15 patches. Check for NDC 53598-0012-15 and Lot# 20150326 with an expiration date of 03/2018. The product is manufactured for Bonita Pharmaceuticals, LLC in Westland, MI.
- Brand
Bonita Pharmaceuticals- Category
Drug
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 3.1 years 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.
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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-0665-2016 (January 27, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0665-2016 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.