← FDA ENFORCEMENT
D-0640-2026Class II

Dabur India 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
Dabur India Limited
Product type
Drug
Status
Ongoing
Report date
2026-06-24
Distribution
US Nationwide.
Product quantity
4,944 tubes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations; deficiencies observed during FDA inspection

Product description

Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured for: Shield Line LLC, 59 Hook Road, Bayonne, NJ 07002 USA, Made in India, UPC 3 52410 30503 0.

Code / lot info

Lot# 001, 002, 013, 016, 031, 032, 033, 045, 046, 047, Within Expiry.

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 →