OVERLOOKED

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Class IIIOngoing

SUN PHARMACEUTICAL INDUSTRIES INC recalls 3 products

Recall date · record updated Oct 14, 2026 · Source: U.S. Food and Drug Administration (openFDA drug enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
SUN PHARMACEUTICAL INDUSTRIES INC
Reason
Failed Impurities/Degradation Specifications
Hazard
FDA Class III: not likely to cause adverse health consequences (FDA definition).
Who’s affected
US Nationwide.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99977…

Products (3)

  1. 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.

    Codes/lots: Lot # AD96184, Exp Date: 12/31/2026.Quantity: N/ARecall no. D-0033-2027Class III

  2. Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02.

    Codes/lots: Lot # AD96183, Exp Date: 12/31/2026.Quantity: N/ARecall no. D-0034-2027Class III

  3. Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0.

    Codes/lots: Lot # AD96196, Exp Date: 12/31/2026.Quantity: N/ARecall no. D-0035-2027Class III

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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