Class III · Low risk
Xelpros (latanoprost ophthalmic emulsion)
Failed Release Testing: Out of specification for particulate matter test.
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
Affected NDC
82187-1002-01
Compare with the code on your package — it is the most precise check available.
Drug: Latanoprost
- Recalling firm
- Aspen Biopharma Labs Pvt., Ltd.
- NDC code
- 82187-1002-1
- Origin
- India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0264-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Latanoprost recalls
See all
Class II · Moderate risk
Timolol-Latanoprost
Subpotent Drug: The batches contain less than 90% of the labeled amount of latanoprost.
Class II · Moderate risk
Timolol- Dorzolamide- Latanoprost P-F
Subpotent Drug
Class II · Moderate risk
Timolol-Latanoprost P-F
Subpotent Drug
Class II · Moderate risk
Timolol-Brimonidine-Dorzolamide-Latanoprost
Incorrect/Undeclared Excipient; non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier
Other recalls by Aspen Biopharma Labs Pvt., Ltd.
All 2025 recalls
Class II · Moderate risk
Voriconazole Container Description: voriconazole The product…
CGMP Deviations
Class II · Moderate risk
Class II · Moderate risk
Class II · Moderate risk
Alprostadil Container Description: Amber color bottle
CGMP Deviations
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