RecallRadar

FDA Drug recall D-0230-2021

Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala,…

On 2021-01-20 the FDA classified a Class II recall of Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala,… by Gaza Proveedora De Servicios De Hospedaje Y Alimentacion, citing cGMP deviations: Product made at the same facility where product tested was sub-potent.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0230-2021
ClassificationClass II
Statusongoing
Initiated2020-12-01
Published2021-01-20
Last updated2026-09-13 11:52 UTC
CompanyGaza Proveedora De Servicios De Hospedaje Y Alimentacion
DistributionTX

Product

Zapien Productos Hand Sanitizer Gel Antibacterial, 33.8 FL. OZ (1000 mL), Made by GAZA S.A. DE C.V. Castilla St. #1473-A ZIP 45410 Tonala, Jalisco, Mexico, UPC: 7 501700 623504, NDC numbers: 76938-001-01, 76938-001-02, 76938-001-03.

Reason

cGMP deviations: Product made at the same facility where product tested was sub-potent.

Identifiers

upc7501700623504
code_infoAll Lots

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0230-2021%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.