FDA recall D-0863-2026

Sterling Pharmaceutical Services LLC · Class II · drug

Product

AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)

Reason for recall

Lack of Assurance of Sterility

Distribution

USA Nationwide

Key facts

Status
Ongoing
Initiation date
2026-08-20
Report date
2026-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Dupo, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0863-2026