FDA · Not Yet Classified · September 23, 2026

Sun Pharmaceutical Industries recall: Nystatin Cream

Sun Pharmaceutical Industries INC is recalling Nystatin Cream – N/A. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on September 14, 2026. Distributed nationwide.

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A pharmacy dispensing machine
Illustration: A pharmacy dispensing machine – not the recalled product. Photo: U.S. Air Force / Airman Trevor Calvert, public domain.
ProductNystatin Cream
BrandSun Pharmaceutical Industries
CompanySun Pharmaceutical Industries INC
TypeDrugs
ClassificationNot Yet Classified
Recall dateSeptember 14, 2026
Published by FDASeptember 23, 2026
QuantityN/A
Recall ID99876
As listed by FDA

Recalled products

  1. 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
    FDA recall number
    N/A
    Codes, lots and dates
    LOT AD49605, LOT AD49606; Exp. 05/31/2027
    Quantity
    N/A
    Classification
    Not Yet Classified
Exactly as the agency lists them

Identifiers and details

FDA event ID
99876
Initiated
Voluntary: Firm initiated
Status
Ongoing
Firm location
Princeton, NJ, United States

Why it was recalled

The reason the FDA lists: “Failed Stability Specifications”

Where it was sold

Nationwide. Distribution as the FDA records it: “U.S. Nationwide.”

What to do

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Official notice: FDA Enforcement Report record (event 99876, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.

Same brand

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FAQ

About this recall

Is Sun Pharmaceutical Industries Nystatin Cream recalled?

Yes. Sun Pharmaceutical Industries INC recalled it on September 14, 2026; FDA published it September 23, 2026 (Not Yet Classified). Only the lots, dates or models listed on this page are included.

Why was it recalled?

Failed Stability Specifications

What should I do if I have it?

Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.

Where was it sold?

Nationwide.

Recalls

More recalls

Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.

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