Prescription eye drops recalled for particulate matter contamination
Sun Pharmaceutical recalls Xelpros latanoprost eye drops (Lot HAD3383A) due to particulate matter contamination detected during release testing. Affected bottles were distributed in Texas and Pennsylvania.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard—particulate matter detected in quality control testing—is theoretical, representing a contamination issue warranting a Moderate classification per the rubric guidance that Class III recalls are typically scored 1 or 2.
Plain-English summary
Xelpros (latanoprost ophthalmic emulsion) 0.005% is a prescription eye medication used to treat elevated eye pressure. Sun Pharmaceutical Industries Inc is recalling approximately 35,069 bottles with Lot number HAD3383A and expiration date August 31, 2024.
The recall was initiated following failed release testing, during which the medication was found to be out of specification for particulate matter. This indicates the presence of particles in the eye drop solution that should not be present.
The affected bottles were distributed in Texas and Pennsylvania. Patients currently using this medication should contact their healthcare provider or pharmacist to determine if they have a recalled bottle and discuss appropriate next steps.
The recalled product
- Product
- XELPROS (LATANOPROST)
- Brand
- XELPROS
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 35,069
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: HAD3383A
- Exp 8/31/2024
Distribution
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