Rapidol Maximum Strength recall
FDA recall D-0428-2025 · initiated Apr 24, 2025
KENIL HEALTHCARE PRIVATE LIMITED recalled Rapidol Maximum Strength in Apr 2025 — an FDA Class II recall (D-0428-2025) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,000 Tubes
Details
- 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.
- Recalling company
- KENIL HEALTHCARE PRIVATE LIMITED
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- DE and NC
- Initiated
- Apr 24, 2025
- FDA report date
- May 28, 2025
Frequently asked
- Was Rapidol Maximum Strength recalled?
- KENIL HEALTHCARE PRIVATE LIMITED recalled Rapidol Maximum Strength in Apr 2025 — an FDA Class II recall (D-0428-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Rapidol Maximum Strength recalled?
- Per the FDA enforcement record, the reason for recall D-0428-2025 was: CGMP Deviations
- Is a recalled Rapidol Maximum Strength dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Rapidol Maximum Strength are affected?
- Distributed: DE and NC. The recall covers these lots — Lot SP26A, Exp: 09/30/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0428-2025.