RecallRadar

FDA Drug recall D-0569-2024

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl…

On 2024-07-03 the FDA classified a Class III recall of SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl… by Neilmed Pharmaceuticals, citing sub-potent Drug.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0569-2024
ClassificationClass III
Statusongoing
Initiated2024-06-24
Published2024-07-03
Last updated2026-09-13 11:52 UTC
CompanyNeilmed Pharmaceuticals
DistributionUS

Product

SinuFrin Decongestant (oxymetazoline HCl) Nasal Solution Nasal Decongestant, Decongestant Relief for up to 12 Hours, 12 Hour Relief, 0.5 fl oz (15 ml) bottle, Manufactured by NeilMed Pharmaceuticals Inc, 602 Aviation Blvd, Santa Rosa, CA 95403 877-477-8633; NDC 13709-325-01; UPC 7 05928 09001 9.

Reason

Sub-potent Drug

Identifiers

upc705928090019
ndc13709-325-01
code_infoLot: SD134; Exp: 10/31/2026

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-0569-2024%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.