FDA Recall D-0487-2026

Island Kinetics, Inc. d.b.a. CoValence Laboratories · Chandler, AZ

Class II Ongoing 43 days on record

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

Product

Blemish Spot Treatment (Salicylic Acid) 1%, .5 fl oz (15 ml) bottles, Skin Script, Chandler, AZ 85226, UPC 6 10563 13873 9.

Lot / code: Lot#: 4228D2, 4229D1, Exp.: 07/31/2026 Lot#: 5147D2, Exp.: 04/30/2027

Quantity: 28,163 bottles

Reason for recall

Failed Stability Specifications

Recall record

Recall number: D-0487-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: U.S. Nationwide
Recall initiated: 2026-04-01
Classified by FDA Center: 2026-04-22
FDA published: 2026-04-22
Recalling firm: Island Kinetics, Inc. d.b.a. CoValence Laboratories
Firm location: Chandler, AZ

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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