Eye allergy medication recalled for out-of-specification impurity
Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II mandatory recall for an out-of-specification impurity in an ophthalmic product. The failed stability test indicates a potential risk-of-harm in a medication applied directly to sensitive eye tissue.
Plain-English summary
Teva Pharmaceuticals USA Inc is recalling Clear Eyes, Once Daily, Eye Allergy Itch Relief (olopatadine hydrochloride ophthalmic solution, USP, 0.2%) due to a failed impurities specification. During stability testing, an out-of-specification result was obtained for an unspecified impurity.
The recall affects 715,632 bottles distributed nationwide in the United States. The product was manufactured in Israel and distributed by Medtech Products Inc, a Prestige Consumer Healthcare company, located in Tarrytown, NY. Affected lot numbers are #114349 (Exp. 05/2023), #117396 (Exp. 09/2023), #120128 (Exp. 11/2023), #114371 (Exp. 06/2023), and #123781 (Exp. 02/2024).
Consumers using the affected product should stop use and contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC…
- Manufacturer
- Teva Pharmaceuticals USA Inc
- Category
- Drug — Ophthalmology / Eye Drops
- Affected units
- 715,632
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 (10)
- Lot #114349
- Exp. 05/2023
- 117396
- Exp. 09/2023
- 120128
- Exp. 11/2023
- 114371
- Exp. 06/2023
- 123781
- Exp. 02/2024.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Teva Pharmaceuticals USA Inc
See all →- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.3 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- ModerateFDA Recalls Pataday Eye Allergy Drops Due to Storage Deviations
FDA (Drugs) · 2022-08-17
- ModerateOlopatadine eye drops recalled after unspecified impurity exceeded specification limit
FDA (Drugs) · 2025-10-29
- ModerateTaro Recalls Children's Allergy Relief Oral Solution Due to Impurity
FDA (Drugs) · 2018-11-21
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereTeva Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
FDA (Drugs) · 2018-12-19
- ModerateMedtech Recalls Clear Eyes Maximum Itchy Eye Relief Drops
FDA (Drugs) · 2019-08-28