RecallRadar

FDA Drug recall D-0426-2020

Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc

On 2019-11-27 the FDA classified a Class II recall of Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc by Altaire Pharmaceuticals, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0426-2020
ClassificationClass II
Statuscompleted
Initiated2019-07-02
Published2019-11-27
Last updated2026-09-13 11:52 UTC
CompanyAltaire Pharmaceuticals
DistributionUS

Product

Altaire Goniotaire Hypromellose 2.5% Opthlamic Demulcent Solution (Sterile), 1/2 fl oz 15 mL, Mfd. by: Altaire Pharmaceuticals, Inc. Aquebogue, NY 11931, NDC 59390-182-13

Reason

Lack of Assurance of Sterility

Identifiers

ndc59390-182-13
code_info17112 4/20 17303 10/20 18032 2/21 18072 3/21 18193 8/20 18235 9/21 18285 11/21 19004 1/22 19102 4/22 16260 9/19

Status history

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

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0426-2020%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.