RecallRadar

FDA Drug recall D-0665-2016

Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches,…

On 2016-02-24 the FDA classified a Class II recall of Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches,… by Bonita Pharmaceuticals, citing marketed without an approved NDA/ANDA.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0665-2016
ClassificationClass II
Statusterminated
Initiated2016-01-27
Published2016-02-24
Last updated2026-09-13 11:51 UTC
CompanyBonita Pharmaceuticals
DistributionUS

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

Marketed without an approved NDA/ANDA

Identifiers

code_infoLot#: 20150326, Exp 03/2018

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0665-2016%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.