USV Private recalled 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution on October 9, 2025. The solution exceeded impurity specifications, posing a health risk. Consumers should stop using the product immediately and contact their healthcare provider.
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Consumers and healthcare providers should stop using this product immediately. Contact USV Private Limited or your healthcare provider for guidance. Notification method: Letter
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The recalled product is Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL bottles. Lot number is 35000409 and expiration date is January 2026. The product was distributed nationwide in the United States.
The product failed to meet impurity specifications. The level of unspecified impurities exceeded acceptable limits, raising concerns about safety.
No specific incidents or injuries have been reported related to this recall. The hazard level is classified as high due to potential health risks.
Consumers and healthcare providers should stop using the product immediately. Contact USV Private Limited or your healthcare provider for guidance regarding the recall.
For further information, contact USV Private Limited. Visit the FDA recall page for additional details.
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