CLASS II Drug recall · Reported 24 Feb 2016 · FDA Enforcement Report
Menthocin Patch with Lidocaine-Strong (Menthol recalled
Bonita Pharmaceuticals is recalling Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate, distributed nationwide in the US. The recall was initiated on 27 Jan 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-0665-2016
- FDA event ID
- 73174
- Recalling firm
- Bonita Pharmaceuticals, Westland, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 27 Jan 2016
- FDA classified
- 12 Feb 2016
- Reported
- 24 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 27 Jan 2016 | Recall initiated by company | |
| 12 Feb 2016 | Classified by FDA | +16 days |
| 24 Feb 2016 | Published in enforcement report | +12 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
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Marketed without an approved NDA/ANDA
Which lots are affected?
Lot#: 20150326, Exp 03/2018
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.