Taro Recalls HEB Clotrimazole Cream Due to Impurity
Taro Pharmaceuticals is recalling HEB Clotrimazole Cream 1% because an unknown degradation impurity was detected slightly above the specification limit.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a minor deviation (impurity slightly above limit) without reporting any illnesses or injuries, fitting the criteria for a moderate severity recall.
Plain-English summary
Taro Pharmaceuticals U.S.A., Inc. is recalling HEB (Clotrimazole) Cream USP, 1% Antifungal, 0.5 oz. (14.2 g). The recall was initiated because an unknown degradation impurity was detected slightly above the specification limit in the product.
The affected product is identified by Lot # A873630558 (Dec-2020) and D867331276 (Exp Mar-2021). The product was distributed nationwide in the USA and Canada.
Consumers should stop using the recalled product and may return it to the place of purchase for a refund or contact Taro Pharmaceuticals for further information.
The recalled product
- Product
- HEB (CLOTRIMAZOLE)
- Brand
- HEB
- Manufacturer
- Taro Pharmaceuticals U.S.A., Inc.
- Category
- Drug — Topical Antifungal
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot#: A873630558 Dec-2020
- D867331276
- Exp Mar-2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Taro Pharmaceuticals U.S.A., Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 10 products in this recall →Related recalls
Same manufacturer · Taro Pharmaceuticals U.S.A., Inc.
See all →- ModerateHydrocortisone & Acetic Acid Otic Solution Recalled for Potency and Impurity Failures
FDA (Drugs) · 2024-08-21
- ModerateClotrimazole and Betamethasone Topical Cream Recalled for Failed Potency Specifications
FDA (Drugs) · 2022-04-06
- SevereClobetasol Propionate Ointment Recalled for Microbial Contamination
FDA (Drugs) · 2022-01-19
- HighTaro Recalls Nortriptyline Hydrochloride Capsules Due to Manufacturing Deviations
FDA (Drugs) · 2021-02-10
- ModerateTaro Recalls Clotrimazole Cream Due to Unknown Degradation Impurity
FDA (Drugs) · 2020-12-23
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateTaro Recalls Clobetasol Propionate Cream Due to Content Uniformity Failure
FDA (Drugs) · 2018-02-07
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
- ModerateClotrimazole and Betamethasone Topical Cream Recalled for Failed Potency Specifications
FDA (Drugs) · 2022-04-06
- ModerateTaro Recalls Children's Allergy Oral Solution Due to Impurity
FDA (Drugs) · 2018-11-21
- ModerateTaro Recalls Desoximetasone Cream Due to Failed Stability Specifications
FDA (Drugs) · 2016-11-09
- LowSun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14