FDA Drug recall D-0158-2021
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g)
- FDA Drug
- Class II
- terminated
- Published 2020-12-23
On 2020-12-23 the FDA classified a Class II recall of TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g) by Taro Pharmaceuticals U, citing failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0158-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-11-17 |
| Published | 2020-12-23 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Taro Pharmaceuticals U |
| Distribution | US |
Product
TopCare Health, Athlete's Foot Cream, Clotrimazole Cream USP, 1%, Antifungal, NET WT. 0.5 oz. (14.2 g). Distributed by Topco Associates LLC, Elk Grove Village, IL 60007. NDC 36800-495-69 UPC 0 36800 49569 2
Reason
Failed Impurities/Degradation Specifications: An unknown degradation impurity was detected slightly above the specification limit in Clotrimazole Cream USP 1%.
Identifiers
| upc | 036800495692 |
|---|---|
| ndc | 36800-495-69 |
| code_info | Lot#: D867331277, Exp Mar 2021 70,200 63,252 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Other recalls by Taro Pharmaceuticals U
- Hydrocortisone 1% & Acetic Acid 2% Otic Solution, 10 mL bottle, Rx only, Mfg by: Taro Pharmaceuticals, Inc., Brampton, Ontario, Canada L6T…
FDA Drug · Class III · 2024-08-21 · Taro Pharmaceuticals U - Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd
FDA Drug · Class III · 2022-04-06 · Taro Pharmaceuticals U - Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dis…
FDA Drug · Class I · 2022-01-19 · Taro Pharmaceuticals U - Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmaceutical Industries Ltd
FDA Drug · Class II · 2021-02-10 · Taro Pharmaceuticals U - Kaiser Permanente Clotrimazole Cream USP, 1% Antifungal Cream, NET WT 1 oz (28.4 g), Manufactured by Taro Pharmaceuticals Inc
FDA Drug · Class II · 2020-12-23 · Taro Pharmaceuticals U
All Taro Pharmaceuticals U recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0158-2021%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.