FDA Drug recall D-0869-2017

Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individua…

FDA Drug
Class III
terminated
Published 2017-06-07

On 2017-06-07 the FDA classified a Class III recall of Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individua… by Vistapharm, citing failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-0869-2017
Classification	Class III
Status	terminated
Initiated	2017-05-17
Published	2017-06-07
Last updated	2026-09-13 11:51 UTC
Company	Vistapharm
Distribution	US

Product

Nystatin Oral Suspension, USP, 100,000 units/mL, packaged in a) 2 fl.oz. (60mL) bottles (NDC 66689-008-02), and 500,000 units/5mL individual unit dose cup (NDC 66689-037-01) packaged in b) 50 count unit dose cups/case (NDC 66689-037-50) and c) 100 count unit dose cups/case (NDC 66689-037-99) Rx only, Manufactured by: VistaPharm, Largo, FL 33771.

Reason

Failed Impurities/Degradation Specifications: Presence of an impurity peak that exceeds approved specification.

Identifiers

code_info	a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500… a) Lot #: 431300, Exp. 01/2018; b) Lot #: 434000, 432500, Exp. 07/2017;462200, Exp. 02/2018 c) Lot #: 443800, 445500, Exp. 09/2017; 460500, 461500, Exp. 01/2018.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0869-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.