Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated Feb 29, 2024 (3 years ago)

hyalogic For Dry Eyes

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility

Cause type: Sterility / contamination

A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.

What was recalled

hyalogic For Dry Eyes, HylaTears", Lubricant Eye Drops, 0.67 FL OZ (20mL) bottle, Manufactured for hyalogic, 610 NW Platte Valley Dr., Riverside, MO 64150

Category: Eye Drops & Ophthalmic

Recalling firm
Optikem International, Inc.
Origin
CO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0384-2024 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other recalls by Optikem International, Inc.

All 2024 recalls

Other sterility / contamination recalls from 2024

All sterility / contamination recalls
Class II · Moderate risk

ketamine inj 50 mg per 1 mL

Lack of Assurance of Sterility: The tamper-evident seal on several of the syringes are not attached upon receipt of shipment.

Terminated Sterility / contamination Hikma Injectables USA Inc NDC 63037-137-25 D-0173-2025