CLASS II Drug recall · Reported 23 Dec 2020 · FDA Enforcement Report
Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal recalled
Taro Pharmaceuticals U is recalling Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, distributed nationwide in the US. The recall was initiated on 17 Nov 2020 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-0154-2021
- FDA event ID
- 86833
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Brand
- Kroger
- Manufacturer
- Kroger Company
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Nov 2020
- FDA classified
- 16 Dec 2020
- Reported
- 23 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 17 Nov 2020 | Recall initiated by company | |
| 16 Dec 2020 | Classified by FDA | +29 days |
| 23 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
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
Kroger Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT 0.5 OZ (15g), Distributed by The Kroger Co. Cincinnati, Ohio 45202 Made in Canada. NDC 30142-305-01
Where it was distributed
Distributed Nationwide in the USA and Canada
Stores named: Kroger
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Which lots are affected?
Lot#: A873430372, Exp Dec 2020; D867331278, Exp Mar 2021
Where was it sold?
Distributed Nationwide in the USA and Canada
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.
Other products in this recall event
9 other products · FDA event 86833More recalls from Taro Pharmaceuticals U
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS I | Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate | Taro Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |
Other Clotrimazole recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Globe Clotrimazole Cream USP, 1 % Antifungal Cream recalledClotrimazole | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Globe Clotrimazole Cream, USP, 1 % recalled by Blossom PharmaceuticalsClotrimazole | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Equate Athlete's Foot, Clotrimazole recalledClotrimazole | Taro Pharmaceuticals U | Potency & Assay | Nationwide |