CLASS III Drug recall · Reported 6 Apr 2022 · FDA Enforcement Report
Clotrimazole and Betamethasone Dipropionate Cream recalled
Taro Pharmaceuticals U is recalling Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05% tubes, distributed in New York. The recall was initiated on 25 Feb 2022 and the FDA has classified it as Class III.
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-0727-2022
- FDA event ID
- 89678
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Feb 2022
- FDA classified
- 29 Mar 2022
- Reported
- 6 Apr 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Creams, Ointments & Gels
Timeline
| 25 Feb 2022 | Recall initiated by company | |
| 29 Mar 2022 | Classified by FDA | +32 days |
| 6 Apr 2022 | 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
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
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
Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, Rx only, Manufactured by: Taro Pharmaceuticals Industries Ltd. Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532, NDC 51672-4048-1
Where it was distributed
Product was distributed to one retail consignee in NY.
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipropionate assay of a stability sample
Which lots are affected?
Lot #: AC33883, Exp. Date June 2023
Where was it sold?
Product was distributed to one retail consignee in NY.
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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.
More 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 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 |
| Drug | CLASS II | Equate Athlete's Foot, Clotrimazole recalledClotrimazole | 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 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 |
| Drug | CLASS II | CVS Health Athlete's Foot Cream, Clotrimazole Cream recalledClotrimazole 1% | Taro Pharmaceuticals U | Potency & Assay | Nationwide |