Menthocin Patch with Lidocaine-Strong — Class II drug recall D-0665-2016
Terminated recall by Bonita Pharmaceuticals, LLC, reported 2016-02-24, distributed nationwide. Marketed without an approved NDA/ANDA
| Recall number | D-0665-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Bonita Pharmaceuticals, LLC, Westland, MI, United States |
| Recall initiated | 2016-01-27 |
| Classified | 2016-02-12 |
| Reported by FDA | 2016-02-24 |
| Terminated | 2019-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 3,308 boxes |
| Reason classes | unapproved product |
| NDC | 53598-0012-15 |
| Lot numbers | 20150326 |
| Expiration dates | 2018-03 |
Product
Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15
Reason for recall
Marketed without an approved NDA/ANDA
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0665-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.