CLASS I Drug recall · Reported 19 Jan 2022 · FDA Enforcement Report
Clobetasol Propionate Ointment USP, 0.05% tubes recalled
Taro Pharmaceuticals U is recalling Clobetasol Propionate Ointment USP, 0.05% tubes, distributed nationwide in the US. The recall was initiated on 15 Dec 2021 and the FDA has classified it as Class I.
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-0375-2022
- FDA event ID
- 89241
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 15 Dec 2021
- FDA classified
- 18 Jan 2022
- Reported
- 19 Jan 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Creams, Ointments & Gels
Timeline
| 15 Dec 2021 | Recall initiated by company | |
| 18 Jan 2022 | Classified by FDA | +34 days |
| 19 Jan 2022 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC 51672-1259-3
Where it was distributed
Two distributors in UT and LA who could have further distributed to the retail level nationwide in the USA.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria
Which lots are affected?
Lot# AC13786, exp. date DEC 2022
Where was it sold?
Two distributors in UT and LA who could have further distributed to the retail level 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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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
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|---|---|---|---|---|---|
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Other Clobetasol Propionate recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clobetasol Propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Ointment, USP, 0.05% tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Cream recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS III | Clobetasol propionate Cream USP, 0.05% tube recalledClobetasol Propionate | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Clobetasol Propionate Lotion 0.05%, Generic for Temovate recalled | Preferred Pharmaceuticals | Potency & Assay | IL |