RecallRadar

FDA Drug recall D-0261-2025

Alprostadil Container Description: Amber color bottle

On 2025-03-19 the FDA classified a Class II recall of Alprostadil Container Description: Amber color bottle by Aspen Biopharma Labs Pvt, citing CGMP Deviations.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0261-2025
ClassificationClass II
Statusongoing
Initiated2025-02-07
Published2025-03-19
Last updated2026-09-13 11:52 UTC
CompanyAspen Biopharma Labs Pvt
DistributionFL

Product

Alprostadil Container Description: Amber color bottle

Reason

CGMP Deviations

Identifiers

code_infoLot Numbers: HAALC0020922 exp. date AUG-2025

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0261-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.