Rapidol Maximum Strength — Class II drug recall D-0428-2025
Terminated recall by KENIL HEALTHCARE PRIVATE LIMITED, reported 2025-05-28, distributed in DE, NC. CGMP Deviations
| Recall number | D-0428-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | KENIL HEALTHCARE PRIVATE LIMITED, Ta. Kadi, District Mehsana, N/A, India |
| Recall initiated | 2025-04-24 |
| Classified | 2025-05-19 |
| Reported by FDA | 2025-05-28 |
| Terminated | 2026-02-19 |
| Distributed | DE, NC |
| Quantity | 10,000 tubes |
| Reason classes | cgmp |
| UPC / GTIN / UDI-DI | 00810096771582 |
| NDC | 55758-0420, 55758-0420-02, 55758-0420-03 |
| Lot numbers | P26A |
| Expiration dates | 2026-09-30 |
Product
Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10096 77158 2.
Reason for recall
CGMP Deviations
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-0428-2025. 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.