Class III · Low risk
Tretinoin Cream USP
Failed Impurities/Degradation Specifications
Tretinoin Cream UPS
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
51672-1394-00
Compare with the code on your package — it is the most precise check available.
Drug: Tretinoin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tretinoin NDC 51672-1394 |
.5 mg/g | Cream Topical |
Sun Pharmaceutical Industries, Inc. | Rx |
- Recalling firm
- Sun Pharmaceutical Industries INC
- NDC code
- 51672-1394-0
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0035-2027 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm.
Other Tretinoin recalls
See all
Class III · Low risk
Tretinoin Cream USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
Class II · Moderate risk
Tretinoin Capsules
Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
Class II · Moderate risk
Formula 82M
Lack of Processing Controls (lack of assurance of conformity to specifications).
Other recalls by Sun Pharmaceutical Industries INC
All 2026 recalls
Class III · Low risk
Tretinoin Cream USP
Failed Impurities/Degradation Specifications
Class III · Low risk
Tretinoin Cream USP
Failed Impurities/Degradation Specifications
Unclassified
Nystatin Cream
Failed Stability Specifications
Class II · Moderate risk
Carbamazepine Tablets
CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
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