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Drug Class III · low Ongoing

Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9.

Failed Impurities/Degradation Specifications

Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
ReasonFailed Impurities/Degradation Specifications
Risk classClass III (Class III · low)
StatusOngoing
Report dateOct 14, 2026
InitiatedSep 25, 2026
RegionNJ, United States
DistributionUS Nationwide.
QuantityN/A
Code/LotLot # AD96184, Exp Date: 12/31/2026.
TypeVoluntary: Firm initiated
Recall numberD-0033-2027

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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