FDA Drugs recall ·
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%… recall
- Recall number
- D-0855-2026
- Date
- (initiated August 20, 2026)
- Company / brand
- Sterling Pharmaceutical Services LLC
109 S 2nd St, Dupo, IL, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 12,864 packs
- Hazard tags
- Sterility
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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
Why was it recalled?
Lack of Assurance of Sterility
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
Distribution
USA Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0855-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.