Clobetasol Propionate Cream — Class III drug recall D-888-2013
Terminated recall by Hi-Tech Pharmacal Co., Inc., reported 2013-08-21, distributed nationwide. Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobe
| Recall number | D-888-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hi-Tech Pharmacal Co., Inc., Amityville, NY, United States |
| Recall initiated | 2013-07-25 |
| Classified | 2013-08-13 |
| Reported by FDA | 2013-08-21 |
| Terminated | 2016-05-16 |
| Distributed | Nationwide (US) |
| Quantity | 58,812 tubes |
| Reason classes | labeling |
| NDC | 50383-0267-15 |
| Lot numbers | 619442 |
| Expiration dates | 2015-01 |
Product
Clobetasol Propionate Cream, USP, 0.05%, 15 grams, Rx only, Hi-Tech PHARMACAL label, Hi-Tech Pharmacal, Co., Inc., Amityville, NY 11701, NDC 50383-267-15 --- For dermatologic use only. Product is packaged into tubes and then placed into unit cartons.
Reason for recall
Labeling: Label Mix-up; some cartons labeled as Clobetasol Propionate Cream USP contain tubes labeled as Clobetasol Propionate Gel USP. The actual product in the tube is Clobetasol Propionate Cream USP
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-888-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.