Diflorasone Diacetate Ointment — Class III drug recall D-0599-2024
Ongoing recall by Rising Pharma Holding, Inc., reported 2024-07-17, distributed nationwide. Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conf
| Recall number | D-0599-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rising Pharma Holding, Inc., East Brunswick, NJ, United States |
| Recall initiated | 2024-06-24 |
| Classified | 2024-07-16 |
| Reported by FDA | 2024-07-17 |
| Distributed | Nationwide (US) |
| Quantity | 868 tubes |
| Reason classes | specification failure |
| NDC | 64980-0124, 64980-0124-03, 64980-0124-15, 64980-0124-45, 64980-0124-60 |
| Lot numbers | DI2303B |
| Expiration dates | 2024-12-31 |
Product
Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising Pharmaceuticals, Inc., East Brunswick, NJ 08816 NDC 64980-124-60
Reason for recall
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
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-0599-2024. 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.