D-0034-2027 Class III Ongoing
FDA drug recall D-0034-2027 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Sep 25, 2026 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 14, 2026
- Initiation Date
- Sep 25, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
Product Description
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
US Nationwide.
Code Information
Lot # AD96183, Exp Date: 12/31/2026.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0034-2027
- openFDA file date
- Oct 19, 2026
- Loaded by RegDataLab
- Oct 21, 2026