← FDA ENFORCEMENT
D-0264-2025Class 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
150.0 gm
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
CGMP Deviations
Product description
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Code / lot info
Lot Numbers: HALAC0010123, exp. date Dec-2026 HALAC0050923, exp. date Aug-2027
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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 →