RecallRadar

FDA Drug recall D-1059-2017

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

On 2017-08-16 the FDA classified a Class II recall of Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61 by X Gen Pharmaceuticals, citing presence of Foreign Substance: potential presence of plastic particles.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1059-2017
ClassificationClass II
Statusterminated
Initiated2017-05-17
Published2017-08-16
Last updated2026-09-13 11:51 UTC
CompanyX Gen Pharmaceuticals
DistributionUS

Product

Nystatin Topical Powder, USP, 100,000 USP units per gram, 15 grams per bottle, Rx only, Vensun, NDC 42543-052-61

Reason

Presence of Foreign Substance: potential presence of plastic particles.

Identifiers

code_infoLot #: 23701.158A, EXP 10/31/18

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-1059-2017%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.