URGENT: DRUG RECALL, Retail Level, Tretinoin Cream, 0.05%
Sun Pharmaceutical Industries, Inc
September,25,2026
Dear Valued Customer,
This notice is to inform you of a product recall involving, Tretinoin 0.05% Cream,
20 g and 45 g; see enclosed product label for ease in identifying the product at the retail level.
(This is a marketed product under the Taro Pharmaceutical label and NorthStar label).
Product Name | Package Description | NDC# | Lot# | Expiration Date |
Tretinoin 0.05% Cream | 45G tube | 51672-1394-9 | AD96184 | 12/31/2026 |
Tretinoin 0.05% Cream | 45G tube | 16714-249-02 | AD96183 | 12/31/2026 |
Tretinoin 0.05% Cream | 20 G tube | 51672-1394-0 | AD96196 | 12/31/2026 |
This recall has been initiated in response to Out of Specification, (OOS), result for impurity, (Impurity-2), during analysis at the 18- month long term stability station, at (25°C, 60%RH).
The Health Hazard Evaluation concluded "the impurity is considered as non-mutagenic. All other critical quality parameters are within specification limit including assay at the 18-month time point. Therefore, it can be concluded that the out of specification result observed for the known impurity, (Impurity 2), against the specification limit of NMT 2.5%, is unlikely to pose any serious safety concern in patients other than the known safety profile of the drug "
The lots complied with all of the established product quality specifications at the time the product was released for distribution.
Sun Pharmaceutical Industries, Inc. initiated shipment of this product on 9/2/2025.
Immediately examine your inventory and quarantine product subject to the recall. In addition, if you have further distributed this product, please identify your retail customers and notify them at once of this product recall. Your notification to your retail customers may be enhanced by including a copy of this recall letter.
Please complete and return the enclosed response form as soon as possible. After receipt of the response form, a return kit will be provided so the affected product can be sent to:
Inmar Rx Solutions 3845 Grand Lakes Way
Grand Prairie, TX 75050
If you have any questions or return the enclosed response form contact Inmar, Inc. at Rxrecalls@Inmar.com or call 866-652- 7566 Monday to Friday from 8:30 am to 5:00 pm (EST).
This recall should be carried out to the retail level.
Your assistance is appreciated and necessary to prevent patient harm.
For adverse reactions or quality problems experienced with the use of this product, contact firm's website or to the FDA's Med Watch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: www.fda.gov/medwatch/report.htm
Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800- 332-1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178
This recall is being made with the knowledge of the Food and Drug Administration.
Regards,
Aster Amanuel
Sun Pharmaceutical Industries, Inc.
Manager, Quality Compliance
For return of affected product, please email Rxrecalls@Inmar.com or call 866-652-7566