Nystatin Cream Medication Recall
Medication recall announcement
Sun Pharmaceutical Industries, Inc
URGENT: DRUG RECALL
Nystatin Cream
RETAIL LEVEL
Sep 10, 2026
Dear Valued Customer,
This notice is to inform you of a product recall involving, Nystatin Cream; see enclosed product label for ease in identifying the product at the retail level.
(This is a marketed product under the Taro Pharmaceutical label).
Product Name | Package Description |
NDC# |
Lot# | Expiration Date |
Nystatin Cream 100,000 Units/G | 15 g | 51672-1289-1 | AD49605 | 05/31/2027 |
30 g |
51672-1289-2 | AD49606 | 05/31/2027 |
This recall has been initiated in response to a quality complaint report for watery texture for Batch AD49605. During homogeneity testing of the 24-month retain sample, Batch AD49605, an Out-of-Specification (OOS) for phase separation was identified. Batch AD49606 is from the same bulk batch as AD49605 and included in the recall.
Based on the Health Hazard Evaluation,
"The watery texture and hardened back end of the Nystatin Cream tube are visible to the naked eye and likely to be identified by the user prior to application; the probability of inadvertent application of the affected cream is therefore considered unlikely.
The observed separation into a free-flowing liquid phase and a hardened cream phase indicates a loss of physical stability and product uniformity. This may result in inconsistent distribution of the active ingredient, subtherapeutic dosing and reduced clinical effectiveness. "
The lot complied with all of the established product specifications at the time the product was released for distribution.
Sun Pharmaceutical Industries, Inc. initiated shipment of this product on December 10, 2024.
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 fonn contact Inmar, Inc. at Rxrecalls@Inmar.com or call 855-319-3840 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.
Xiomara Lesniak
Sun Pharmaceutical Industries, Inc.
Sr Manager, Quality Compliance
For return of affected product, please email Rxrecalls@Inmar.com or call 855-319-3840