CLASS II ONGOING Drug recall · Reported 7 Oct 2026 · FDA Enforcement Report
Focus PI Hypromellose 0.7% Formula, 0.3 FL O per vial, Sterile recalled
Aurolab Trust is recalling Focus PI Hypromellose 0.7% Formula, 0.3 FL O per vial, Sterile, distributed in Virginia. The recall was initiated on 17 Sep 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0874-2026
- FDA event ID
- 99903
- Recalling firm
- Aurolab Trust, Madurai
- Brand
- Focus Pi
- Manufacturer
- COVALENT MEDICAL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 17 Sep 2026
- FDA classified
- 28 Sep 2026
- Reported
- 7 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 17 Sep 2026 | Recall initiated by company | |
| 28 Sep 2026 | Classified by FDA | +11 days |
| 7 Oct 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
VA
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Batch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28
Where was it sold?
VA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 13 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.