The Recall Desk
HighFDA (Drugs)·D-0263-2025·Announced 2025-03-19

Chemotherapy drug Chlorambucil recalled for manufacturing process deviations

Aspen Biopharma Labs is voluntarily recalling Chlorambucil due to manufacturing process deviations. The product was distributed to distributors in Hong Kong and Florida.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a chemotherapy drug with manufacturing process deviations meets the rubric criterion for a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.

Plain-English summary

Aspen Biopharma Labs Pvt., Ltd. is voluntarily recalling Chlorambucil due to deviations from Current Good Manufacturing Practice (CGMP) regulations. The recalled product includes lot numbers HACUC0010722 (expiring June 2025) and HACUC0010123 (expiring December 2025), totaling 5.1 kg.

The affected product was distributed to three distributors: one in Hong Kong and two accounts in Florida. The manufacturer initiated the recall on February 7, 2025, and the FDA classified it as Class II on March 9, 2025.

This is a voluntary recall by the firm. No illnesses or injuries related to this product have been reported.

The recalled product

Product
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Manufacturer
Aspen Biopharma Labs Pvt., Ltd.
Category
Drug — Chemotherapy
Hazard
  • cgmp-deviation
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

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

Distribution

Distribution scope not specified by the agency.

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