FDA Recall D-0350-2026

Wizcure Pharmaa Private Limited · Bhiwadi, N/A

Class II Ongoing 134 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,

Lot / code: All lots

Quantity: 10,080 boxes

Reason for recall

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Recall record

Recall number: D-0350-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed Nationwide in the USA
Recall initiated: 2025-12-31
Classified by FDA Center: 2026-02-25
FDA published: 2026-03-04
Recalling firm: Wizcure Pharmaa Private Limited
Firm location: Bhiwadi, N/A, India

Drug identification

Brand name(s): C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS
Generic name(s): FLUORESCEIN SODIUM
Manufacturer(s): Vistamerica USA
NDC(s): 83851-100
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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