Nystatin: 6 recalls on record

Recalled by 1 agency: FDA (6).

First recall on record: June 13, 2018. Most recent: July 22, 2026.

Risk classification: Class II: 5 · Class III: 1

Most recent recalls

DateAgencyProduct
July 22, 2026FDANystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufa…D-0677-2026
August 18, 2021FDANystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, p…D-0721-2021
August 19, 2020FDANystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. …D-1494-2020
April 1, 2020FDANystatin Oral Suspension, USP, 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl oz (…D-1060-2020
February 5, 2020FDANystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (47…D-0824-2020
June 13, 2018FDANystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged …D-0865-2018

Questions about this brand

How many recalls does Nystatin have?
Recalert has 6 U.S. recalls on record for Nystatin, published between June 13, 2018 and July 22, 2026.
What was the most recent Nystatin recall?
FDA recall D-0677-2026, published July 22, 2026: Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g tube, Manufactured by Padagis, Yeruham, Israel, NDC 45802-059-35
Which agencies have recalled Nystatin products?
Nystatin products appear in recalls from: FDA (6).

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