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Urgent Enforcement Amended Final

Class II Recall: Preferred Pharmaceuticals Artificial Tears Eye Drops

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Summary

FDA classified a Class II recall initiated by Preferred Pharmaceuticals for Artificial Tears Lubricant Eye Drops (NDC 68788-7266) due to lack of assurance of sterility. The recall covers 720 bottles across six lot numbers (F1924R, F2024G, F2424E, G2424M, G2624P, J2424M) distributed nationwide. The firm initiated the recall on March 25, 2026; FDA classification occurred on April 7, 2026.

“Lack of Assurance of Sterility”

FDA , verbatim from source
Published by FDA on changeflow.com . Detected, standardized, and enriched by GovPing. Review our methodology and editorial standards .

What changed

Preferred Pharmaceuticals voluntarily initiated a recall of 720 bottles of Artificial Tears Lubricant Eye Drops manufactured by Geri-Care (Brooklyn, NY) after concerns arose regarding sterility assurance. FDA classified the recall as Class II, indicating temporary or reversible health consequences where use of the product may cause adverse health consequences or a remote possibility of serious health consequences.

Healthcare providers, pharmacies, and distributors that received this product should verify their inventory against the six affected lot numbers (F1924R, F2024G, F2424E, G2424M, G2624P, J2424M) and should not dispense bottles from these lots. Patients experiencing any adverse events associated with use of this product should consult their healthcare provider.

Archived snapshot

Apr 20, 2026

GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.

Preferred Pharmaceuticals, Inc.

Drug Recalls (Class II)

← All Drug Recalls (Class II) Class II D-0443-2026 · 20260415 · Ongoing · Voluntary: Firm initiated

Product

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0

Reason for Recall

Lack of Assurance of Sterility

Affected Lot Numbers / Codes

Lot #: F1924R, F2024G, F2424E, G2424M, G2624P, J2424M

Quantity

720 bottles

Distribution

Nationwide within the United States

Initiated

20260325

FDA Classified

20260407

Product Registration

Brand: ARTIFICIAL TEARS

Generic: GLYCERIN

Manufacturer: Preferred Pharmaceuticals Inc.

Application: MO18

NDC: 68788-7266

Drug Label Context (from openFDA)

The following is from the manufacturer's FDA-approved drug label, not recall-specific. Provided for context.

Indications & Usage

Uses • for protection against further irritation • for temporary relief of burning and irritation due to dryness of the eye

Dosage & Administration

Directions • instill 1 or 2 drops in the affected eye(s) as needed • children under 6 years of age: ask a doctor

Warnings

Warnings For external use only Do not use this product if solution changes color or becomes cloudy

Storage & Handling

Other information • store at 15°-30°C (59°-86°F)

Sources: openFDA · Raw JSON

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Last updated

Classification

Agency
FDA
Filed
April 15th, 2026
Instrument
Enforcement
Branch
Executive
Legal weight
Binding
Stage
Final
Change scope
Substantive
Document ID
D-0443-2026

Who this affects

Applies to
Pharmaceutical companies Healthcare providers Patients
Industry sector
3254 Pharmaceutical Manufacturing
Activity scope
Drug recall response Quality assurance review
Geographic scope
United States US

Taxonomy

Primary area
Pharmaceuticals
Operational domain
Clinical Operations
Compliance frameworks
GxP
Topics
Healthcare Medical Devices

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