← FDA ENFORCEMENT
D-0855-2026Class II

Sterling Pharmaceutical Services LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Sterling Pharmaceutical Services LLC
Product type
Drug
Status
Ongoing
Report date
2026-09-30
Distribution
USA Nationwide
Firm state
IL
Product quantity
12,864 packs
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →