FDA Drug recall D-0035-2027
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuti…
- FDA Drug
- Class III
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class III recall of Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuti… by Sun Pharmaceutical Industries, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0035-2027 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2026-09-25 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | US |
Product
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.
Reason
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 51672-1394-0 |
|---|---|
| ndc | 51672-1394-9 |
| code_info | Lot # AD96196, Exp Date: 12/31/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Sun Pharmaceutical Industries
- Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., B…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmac…
FDA Drug · Class III · 2026-10-14 · Sun Pharmaceutical Industries - Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 262…
FDA Drug · Class II · 2026-08-26 · Sun Pharmaceutical Industries - Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets per bottle, Distributed by: Ohm Laboratories, Inc., New Brunswic…
FDA Drug · Class III · 2026-07-08 · Sun Pharmaceutical Industries - Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Dist. by: Sun Ph…
FDA Drug · Class II · 2026-07-01 · Sun Pharmaceutical Industries
All Sun Pharmaceutical Industries recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0035-2027%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.