Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle recall
FDA recall D-0264-2025 · initiated Feb 7, 2025
Aspen Biopharma Labs Pvt., Ltd. recalled Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle in Feb 2025 — an FDA Class II recall (D-0264-2025) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 150.0 gm
Details
- Product
- Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
- Recalling company
- Aspen Biopharma Labs Pvt., Ltd.
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida)
- Initiated
- Feb 7, 2025
- FDA report date
- Mar 19, 2025
Frequently asked
- Was Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle recalled?
- Aspen Biopharma Labs Pvt., Ltd. recalled Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle in Feb 2025 — an FDA Class II recall (D-0264-2025) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle recalled?
- Per the FDA enforcement record, the reason for recall D-0264-2025 was: CGMP Deviations
- Is a recalled Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle are affected?
- Distributed: Product was distributed to 3 distributors (1 Hong Kong and 2 accounts in Florida). The recall covers these lots — Lot Numbers: HALAC0010123, exp. date Dec-2026 HALAC0050923, exp. date Aug-2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0264-2025.