RecallReported October 14, 2026
Class III recall by SUN PHARMACEUTICAL INDUSTRIES INC
Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmace…
FDA's enforcement report of October 14, 2026 lists a Class III recall by SUN PHARMACEUTICAL INDUSTRIES INC of Princeton, NJ. Product: Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmace…. Status: Ongoing.
On the record
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Location
- Princeton, NJ
- Classification
- Class III
- Status
- Ongoing
- Recall number
- D-0033-2027
- Product type
- Drugs
- Brand names
- TRETINOIN
- Generic names
- TRETINOIN
- Recall initiated
- 2026-09-25
- Reported by FDA
- 2026-10-14
The full record
An account shows the reason for the recall, where the product was distributed and the lots.
What a recall is
FDA classifies a recall by the hazard. Class I: a reasonable probability that the product will cause serious adverse health consequences or death. Class II: the product may cause temporary or medically reversible harm, or the probability of serious harm is remote. Class III: the product is not likely to cause adverse health consequences.
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From FDA enforcement reports. The record may have changed since it was read.
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