Clocortolone Pivalate Cream — Class III drug recall D-0598-2018
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-03-21, distributed nationwide. Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
| Recall number | D-0598-2018 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2018-03-08 |
| Classified | 2018-03-14 |
| Reported by FDA | 2018-03-21 |
| Terminated | 2019-04-29 |
| Distributed | Nationwide (US) |
| Quantity | 4,152 tubes |
| Reason classes | specification failure |
| NDC | 43598-0341-90 |
Product
Clocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
Reason for recall
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
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-0598-2018. 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.