Sun Pharmaceutical recalls Tretinoin Cream USP, 0.05% because it failed impurities and degradation specifications
The tretinoin cream, 0.05%, in 20 g and 45 g sizes, failed its impurities and degradation specifications, and the notice is classed as Class III and ongoing.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall details
- Product
- 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.; 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…
- Hazard
- Failed Impurities/Degradation Specifications
- Units
- N/A
- Where sold
- US Nationwide.
- FDA classification
- Class III · Ongoing
- Classified by FDA
- October 8, 2026
- Recall started
- September 25, 2026
- FDA enforcement report
- October 14, 2026
- Identifiers
- Codes: Lot # AD96183, Exp Date: 12/31/2026.
- FDA recall number: D-0034-2027
- Codes: Lot # AD96196, Exp Date: 12/31/2026.
- FDA recall number: D-0035-2027
- Codes: Lot # AD96184, Exp Date: 12/31/2026.
- FDA recall number: D-0033-2027
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- Product
- 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. | 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. | 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.
- Reason for recall
- Failed Impurities/Degradation Specifications
- Classification
- Class III (Ongoing)
- Distribution
- US Nationwide.
- Quantity
- N/A
Related recalls
Sun Pharmaceutical recalls fluocinonide 0.05% cream because it was too thick in stability testing
Stability testing found the cream's viscosity (thickness) was above the allowed limit, meaning it did not meet its quality specification.
Sun Pharmaceutical Industries INC · 69,024 units
Sun Pharmaceutical recalls Fluocinolone Acetonide topical solution over failed impurity test
A test of the 0.01% topical solution in 60-mL bottles found more of a known impurity, called impurity D, than allowed, so the product failed its quality limits.
Sun Pharmaceutical Industries INC · 24,624 bottles
Sun Pharmaceutical recalls clindamycin 1% topical solution over failed impurity and strength tests
Tests of this clindamycin skin solution, sold in 60 mL applicator bottles, found results outside the allowed limits for total impurities and for the amount of active ingredient (assay).