Multi-event February 2025 FDA Recall Drug by Aspen Biopharma Labs Pvt., Ltd.
This Multi-event Class II drug recall was voluntarily initiated by Aspen Biopharma Labs Pvt., Ltd. on February 7, 2025 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed in Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida) and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0263-2025
CGMP Deviations
02-07-2025
03-19-2025
5.1 kg
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aspen Biopharma Labs Pvt., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Batch or Lot Expiration Information
Lot# Lot Numbers: HACUC0010722, exp. date Jun-2025 HACUC0010123, exp. date Dec-2025
Recall Number: D-0261-2025
CGMP Deviations
02-07-2025
03-19-2025
3.0 gm
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aspen Biopharma Labs Pvt., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Alprostadil Container Description: Amber color bottle
Batch or Lot Expiration Information
Lot# Lot Numbers: HAALC0020922 exp. date AUG-2025
Recall Number: D-0265-2025
CGMP Deviations
02-07-2025
03-19-2025
4.0 kg
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aspen Biopharma Labs Pvt., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Batch or Lot Expiration Information
Lot# Lot Number: HAVZC0020922, exp. date AUG-2026
Recall Number: D-0262-2025
CGMP Deviations
02-07-2025
03-19-2025
120.0 kg
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aspen Biopharma Labs Pvt., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Finasteride NDC# 82187-1003-1 Container Description: The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
Batch or Lot Expiration Information
Lot# Lot Numbers: HAFSC0040923, exp. date Aug-2027 HAFSC0050923, exp. date Aug-2027
Recall Number: D-0264-2025
CGMP Deviations
02-07-2025
03-19-2025
150.0 gm
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aspen Biopharma Labs Pvt., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Batch or Lot Expiration Information
Lot# Lot Numbers: HALAC0010123, exp. date Dec-2026 HALAC0050923, exp. date Aug-2027
Recall Number: D-0260-2025
CGMP Deviations
02-07-2025
03-19-2025
400.0 gm
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aspen Biopharma Labs Pvt., Ltd.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Bimatoprost NDC# 82187-1001-1 Container description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
Batch or Lot Expiration Information
Lot# Lot Numbers: HABTC0020123, exp. date Dec-2026 HABTC0050623, exp. date May-2027 HABTC0091023, exp. date Sep-2028
