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FDAClass III

Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampto… Recalled: Failed Impurities/Degradation Specifications

Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro… was recalled on September 25, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications.

Is my unit affected?

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.

Model, lot & date codes to check

Lot # AD96184, Exp Date: 12/31/2026.

Units affected: N/A

Where it was sold: US Nationwide.

Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.

What's the hazard?

Failed Impurities/Degradation Specifications

Class III means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.

Your remedy & how to claim it

Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.

Contact: Recalling firm: SUN PHARMACEUTICAL INDUSTRIES INC

Not sure what you're entitled to? Read our guide: what to do if your product is recalled.

Official recall notice

Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.

View official notice →

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