CLASS III ONGOING Drug recall · Reported 29 May 2024 · FDA Enforcement Report
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg recalled
SUN Pharmaceutical Industries is recalling Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg, distributed in Pennsylvania, Texas. The recall was initiated on 22 Apr 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0502-2024
- FDA event ID
- 94465
- Recalling firm
- SUN Pharmaceutical Industries, Princeton, NJ
- Brand
- Xelpros
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 22 Apr 2024
- FDA classified
- 20 May 2024
- Reported
- 29 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Eye Drops
Timeline
| 22 Apr 2024 | Recall initiated by company | |
| 20 May 2024 | Classified by FDA | +28 days |
| 29 May 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Release Testing: Out of specification for particulate matter test.
Product as listed by the FDA
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Where it was distributed
TX, PA
Questions about this recall
Why was it recalled?
Failed Release Testing: Out of specification for particulate matter test.
Which lots are affected?
Lot #: HAD3383A, Exp 8/31/2024
Where was it sold?
TX, PA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Latanoprost recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Latanoprost Ophthalmic Solution, 0.005%, 125 ug recalled by Akorn | Akorn | Sterility | Nationwide |
| Drug | CLASS II | Latanoprost Ophthalmic Solution, 0.005% (125 mcg recalled by Apotex | Apotex | Sterility | Nationwide |