CLASS II Drug recall · Reported 21 Aug 2019 · FDA Enforcement Report
CVS Therapeutic Menthol Gel recalled by US Pharmaceuticals
US Pharmaceuticals is recalling CVS Therapeutic Menthol Gel, distributed nationwide in the US. The recall was initiated on 11 Jul 2019 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-1726-2019
- FDA event ID
- 83316
- Recalling firm
- US Pharmaceuticals, Belleville, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Jul 2019
- FDA classified
- 13 Aug 2019
- Reported
- 21 Aug 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 11 Jul 2019 | Recall initiated by company | |
| 13 Aug 2019 | Classified by FDA | +33 days |
| 21 Aug 2019 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
CVS Therapeutic Menthol Gel, 8 FL OZ (227 g) Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 48136 3
Where it was distributed
Distributed Nationwide in the USA
Stores named: CVS
Questions about this recall
Is CVS Therapeutic Menthol Gel recalled?
Yes. US Pharmaceuticals recalled CVS Therapeutic Menthol Gel on 11 Jul 2019. The recall is Class II and its status is Terminated. Recall number D-1726-2019.
Why was it recalled?
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Which lots are affected?
Lot #'s 28L17, 31L17, 36L17, 40L17, 44L17 EXP 09/2019; 05M17, 09M17, 12M17, 13M17, 23M17 EXP 10/2019; 69P17, 72P17 EXP 11/2019; 42S17, 46S17 EXP 12/2019; 85C18, 86C18 EXP 03/2020; 31J18, 43J18, 55J18, 58J18, 18L18 EXP 07/2020.
Where was it sold?
Distributed Nationwide in the USA
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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