Quick Facts at a Glance
- Recall Date
- October 9, 2025
- Hazard Level
- HIGH
- Brand
- USV Private
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- USV Private
- Product type
- Ophthalmic solution
- Model numbers
- 35000409
- Sizes
- 5 mL
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
October 9, 2025
Reported by FDA DRUG
October 29, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact USV Private Limited or your healthcare provider for guidance. Notification method: Letter
About This Product
Olopatadine hydrochloride ophthalmic solution is used to treat allergic conjunctivitis by reducing itching in the eyes.
Why This Is Dangerous
The product failed impurity/degradation specifications due to an unspecified impurity exceeding the limit. The exact health impact is not detailed in the recall.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Consumers may face unknown health risks from the impurity. The recall affects nearly 9,000 bottles, requiring immediate discontinuation of use and guidance from a healthcare provider.
Practical Guidance
How to identify if yours is affected
- Verify NDC 70512-0520-05 on the bottle.
- confirm bottle size is 5 mL.
Where to find product info
Label on bottle and external packaging showing NDC, Lot, Exp date; FDA recall page for D-0034-2026.
What timeline to expect
Refunds or replacements are typically processed within 4-8 weeks after confirmation of eligibility.
If the manufacturer is unresponsive
- File a complaint with the FDA if the company is unresponsive.
- Consider state consumer protection or other regulatory channels.
- Consult your healthcare provider for interim guidance.
How to prevent similar issues
- Always verify NDC codes before purchasing new ophthalmic solutions.
- Keep recall notices and packaging until the case is resolved.
- Ask for official recall letters and track updates from the manufacturer and FDA.
Documentation advice
Keep the recall letter, photos of the bottle labeling, and all communications with the company. Preserve the bottle and packaging for reference.
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Product Details
Product: Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% 5 mL (0.17 FL OZ) bottles NDC: 70512-0520-05 Lot: 35000409 Exp: 01/2026 Quantity: 8,952 bottles Distributor/Manufacturer: SOLA PHARMACEUTICS LLC, Baton Rouge, LA 70810 Sold nationwide in the United States Price: Not provided
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Nationwide US distribution
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Safety Guide
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