RecallRadar

FDA Drug recall D-0874-2026

FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109

On 2026-10-07 the FDA classified a Class II recall of FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109 by Aurolab Trust, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0874-2026
ClassificationClass II
Statusongoing
Initiated2026-09-17
Published2026-10-07
Last updated2026-10-13 05:30 UTC
CompanyAurolab Trust
DistributionVA

Product

FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, Manufactured for: Covalent Management, Inc., Manassas, VA 20109. NDC: 82724-007-19

Reason

Lack of Assurance of Sterility

Identifiers

ndc82724-007-19
code_infoBatch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-10-13 05:30 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0874-2026%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.