Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recall
FDA recall D-0034-2026 · initiated Oct 9, 2025
USV Private Limited recalled Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % in Oct 2025 — an FDA Class II recall (D-0034-2026) because Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 8,952 bottles
Details
- 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
- Recalling company
- Usv Private Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Oct 9, 2025
- FDA report date
- Oct 29, 2025
Frequently asked
- Was Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recalled?
- USV Private Limited recalled Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % in Oct 2025 — an FDA Class II recall (D-0034-2026) because Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recalled?
- Per the FDA enforcement record, the reason for recall D-0034-2026 was: Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
- Is a recalled Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: 35000409, Exp. Date 01/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0034-2026.