CLASS II Drug recall · Reported 28 May 2025 · FDA Enforcement Report
Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream recalled
Kenil Healthcare Private is recalling Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, distributed in Delaware, North Carolina. The recall was initiated on 24 Apr 2025 and the FDA has classified it as Class II.
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-0428-2025
- FDA event ID
- 96797
- Recalling firm
- Kenil Healthcare Private, Ta. Kadi, District Mehsana, N/A
- Brand
- Rapidol
- Manufacturer
- Pharmadel LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Apr 2025
- FDA classified
- 19 May 2025
- Reported
- 28 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 24 Apr 2025 | Recall initiated by company | |
| 19 May 2025 | Classified by FDA | +25 days |
| 28 May 2025 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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.
Where it was distributed
DE and NC
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot SP26A, Exp: 09/30/2026
Where was it sold?
DE and NC
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
19 other products · FDA event 96797This product is part of a recall event; the main page for the event is Nature Mint Anticavity Fluoride Toothpaste recalled.
More recalls from Kenil Healthcare Private
All 20Other Hydrocortisone recalls
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP dropper recalledHydrocortisone And Acetic Acid | Taro Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone and Acetic Acid Otic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydrocortisone Ointment recalled by Mckesson Medical-SurgicalHydrocortisone | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Hydrocortisone Acet 30mg recalled by Cardinal HealthHydrocortisone Acetate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% recalled | The Medicine Shoppe Pharmacy | Other | FL |