RecallRadar

FDA Drug recall D-0450-2020

OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc

On 2019-11-27 the FDA classified a Class II recall of OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc by Altaire Pharmaceuticals, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0450-2020
ClassificationClass II
Statuscompleted
Initiated2019-07-02
Published2019-11-27
Last updated2026-09-13 11:52 UTC
CompanyAltaire Pharmaceuticals
DistributionUS

Product

OCuSOFT Tears Again Lubricant Eye Drops, Net Wt. 15 mL (0.5 fl oz), Manufactured for OCuSOFT Inc. Rosenberg, TX 77471 USA, NDC 54799-904-15

Reason

Lack of Assurance of Sterility

Identifiers

code_info17209 7/21 18168 7/22 18217 8/22 18260 10/22 19094 4/23

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-0450-2020%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.