FDA Recall D-0263-2025
Aspen Biopharma Labs Pvt., Ltd.
Class II Ongoing 461 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Reason for recall
CGMP Deviations
Recall record
- Recall number
D-0263-2025- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
- Recall initiated
- 2025-02-07
- Classified by FDA Center
- 2025-03-09
- FDA published
- 2025-03-19
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.