CLASS III Drug recall · Reported 19 Aug 2020 · FDA Enforcement Report
Clobetasol Propionate Cream USP, 0.05%, a) tube recalled
Taro Pharmaceuticals U is recalling Clobetasol Propionate Cream USP, 0.05%, a) tube, distributed nationwide in the US. The recall was initiated on 20 Jul 2020 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-1496-2020
- FDA event ID
- 86101
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 20 Jul 2020
- FDA classified
- 12 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 20 Jul 2020 | Recall initiated by company | |
| 12 Aug 2020 | Classified by FDA | +23 days |
| 19 Aug 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 Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Product as listed by the FDA
Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Which lots are affected?
a) AB28353, Exp 12/31/2021; b) AB40178, Exp 12/31/2021
Where was it sold?
Nationwide in the U.S.
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 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 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 |