CLASS II ONGOING Drug recall · Reported 29 Oct 2025 · FDA Enforcement Report
Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 % recalled
USV Private is recalling Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, distributed nationwide in the US. The recall was initiated on 9 Oct 2025 and the FDA has classified it as Class II.
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-0034-2026
- FDA event ID
- 97766
- Recalling firm
- USV Private, Dabhel, Daman
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 9 Oct 2025
- FDA classified
- 20 Oct 2025
- Reported
- 29 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 9 Oct 2025 | Recall initiated by company | |
| 20 Oct 2025 | Classified by FDA | +11 days |
| 29 Oct 2025 | 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 Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.
Which lots are affected?
Lot #: 35000409, Exp. Date 01/2026
Where was it sold?
Nationwide within the United States
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other Olopatadine recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ryaltris (olopatadine hydrochloride recalled by Glenmark PharmaceuticalsRyaltris | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS II | Olopatadine HCl Nasal Spray, 665 mcg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Olopatadine HCl Ophthalmic Solution recalled by Akorn | Akorn | Manufacturing (CGMP) Deviations | Nationwide |