September 2026 FDA Recall Focus Pi by Aurolab Trust
D-0874-2026 - Lack of Assurance of Sterility

This Class II drug recall was voluntarily initiated by Aurolab Trust on September 17, 2026 for the product Focus Pi. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed in VA and the recall is currently ongoing.

Recall Number: D-0874-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
09-17-2026
Reported
10-07-2026
Quantity
25,220 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
99903
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Aurolab Trust
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
VA
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Batch# 6B093FI, Exp. 04/01/28
Batch# 6F511F1, Exp. 05/15/28

Affected Packages Involved in this Recall

82724-007-19 Focus Pi