FDA-Drug2026-09-30Class IIPROCESSING DEFECT
AvKare Carboxymethylcellulose Sodium eye drops recalled for sterility assurance failure
What this means
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% lubricant eye drops failed to meet sterility standards. The product was distributed nationwide in 15 mL bottles across nine affected lot numbers with expiration dates ranging from August 2026 to July 2027. Use of non-sterile eye drops can introduce bacteria or other microorganisms into the eye.
- Check if you have an AvKare lubricant eye drops bottle with one of the affected lot numbers (3161, 3245, 3260, 3298, 3299, 3300, 3301, 3302, 3305, or 3306).
- Stop using the product if you have one of these lot numbers.
- Contact your pharmacy or healthcare provider for a replacement or alternative eye drop product.
- Dispose of the recalled bottle safely.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
12,864 packs
Manufactured in
109 S 2nd St, Dupo, IL, United States
Products
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0855-2026More Sterling Pharmaceutical Services recalls
- FDA-Drug2026-09-30Reliable-1 Laboratories Lubricating Tears recalled for lack of sterility assurance
- FDA-Drug2026-09-30Walgreens Lubricant Eye Drops recalled for lack of sterility assurance
- FDA-Drug2026-09-30Major LubriFresh P.M. Nighttime Ointment recalled for lack of sterility assurance
- FDA-Drug2026-09-30Reliable-1 Laboratories Sodium Chloride 5% eye solution recalled for sterility assurance
- FDA-Drug2026-09-30Walgreens Lubricant Eye Drops recalled for lack of sterility assurance
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