Class III · Lower riskActive recall
Tretinoin
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot # AD96183, Exp Date: 12/31/2026.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Failed Impurities/Degradation Specifications
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byTaro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada foreign manufacturer
| Brand name | TRETINOIN |
| Generic name | TRETINOIN |
| Active ingredient(s) | TRETINOIN |
| Distributed by / for | Northstar Rx LLC, Memphis, TN 38141 |
| NDC | 16714-249-02 |
Show the full FDA record
| Full product label | 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. |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC |
| Distribution | US Nationwide. |
| Quantity | N/A |
| Recall initiated | 2026-09-25 |
| Report date | 2026-10-14 |
| Recall completed | — |
| Recall number | D-0034-2027 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Princeton NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.