Olopatadine eye drops recalled after unspecified impurity exceeded specification limit
USV Private Limited is recalling 8,952 bottles of Olopatadine Hydrochloride Ophthalmic Solution USP 0.1% after an unspecified impurity exceeded the specification limit.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: Scored 2 as a specification failure: the record cites an unspecified impurity above limit without naming it, describing a health consequence, or reporting injury.
Plain-English summary
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1%, in 5 mL bottles, manufactured for Sola Pharmaceuticals of Baton Rouge, Louisiana, is being recalled for failed impurities and degradation specifications. The result for any individual unspecified impurity exceeds the specification limit.
The recall covers 8,952 bottles from lot 35000409, expiring January 2026, carrying NDC 70512-0520-05. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
The enforcement record states the specification failure without naming the impurity or describing a health consequence, and reports no injuries.
Patients holding the affected lot should contact their pharmacy or prescriber about a replacement.
The recalled product
- Product
- Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles, Manufactured for: SOLA PHARMACEUTICALS LLC, Baton Rouge, LA 70810, NDC 70512-0520-05
- Manufacturer
- USV Private Limited
- Category
- Drug — Ophthalmic solution
- Affected units
- 8,952
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 #: 35000409
- Exp. Date 01/2026
Distribution
Distributed nationwide across the United States.
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