FDA Drugs recall ·

Latanoprost recall

Recall number
D-0264-2025
Date
(initiated February 7, 2025)
Company / brand
Aspen Biopharma Labs Pvt., Ltd.
Plot No 10, Biotech Park Phase-II, Medchal Malkajgiri, India
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
150.0 gm
Hazard tags
Manufacturing practices (cGMP)
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle

Why was it recalled?

CGMP Deviations

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot Numbers: HALAC0010123, exp. date Dec-2026 HALAC0050923, exp. date Aug-2027

Distribution

Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)

States: Florida

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0264-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.