← FDA ENFORCEMENT
D-0428-2025Class II
KENIL HEALTHCARE PRIVATE LIMITED
What this record is not
A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.
Recalling firm
KENIL HEALTHCARE PRIVATE LIMITED
Product type
Drug
Status
Terminated
Report date
2025-05-28
Distribution
DE and NC
Firm state
N/A
Product quantity
10,000 Tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations
Product description
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.
Code / lot info
Lot SP26A, Exp: 09/30/2026
Other recalls SPEQ maps to Risk Management & CAPA
2026-10-21Class IIHouston Rx LLC2026-10-21Class IICook Incorporated2026-10-21Class IIBaxter Healthcare Corporation2026-10-14Class IIQUANTUM OPS Inc
See all Risk Management & CAPA recalls →Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →