← FDA ENFORCEMENT
D-0263-2025Class II

Aspen Biopharma Labs Pvt., Ltd.

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
Aspen Biopharma Labs Pvt., Ltd.
Product type
Drug
Status
Ongoing
Report date
2025-03-19
Distribution
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product quantity
5.1 kg
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

CGMP Deviations

Product description

Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.

Code / lot info

Lot Numbers: HACUC0010722, exp. date Jun-2025 HACUC0010123, exp. date Dec-2025

Other recalls SPEQ maps to Risk Management & CAPA
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 →