September 2026 FDA Recall Nystatin by Sun Pharmaceutical Industries Inc
N/A - Failed Stability Specifications

This Not Yet Classified drug recall was voluntarily initiated by Sun Pharmaceutical Industries Inc on September 14, 2026 for the product Nystatin. The FDA reported the reason for recall as failed stability specifications. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: N/A

Reason for Recall
Failed Stability Specifications
Initiated
09-14-2026
Reported
09-23-2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99876
Classification About Classification
Relative degree of health hazard assigned by FDA.
Not Yet Classified
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
SUN PHARMACEUTICAL INDUSTRIES INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
U.S. Nationwide.
Product Description About Product Description
Full technical description of the product.
Nystatin Cream, USP, 15 g per tube, Rx only, Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761; Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. NDC: 51672-1289-1

Batch or Lot Expiration Information

Lot# LOT AD49605, LOT AD49606; Exp. 05/31/2027

Affected Packages Involved in this Recall

51672-1289-1 Nystatin
51672-1289-2 Nystatin