FDA-Drug2026-10-07Class IIPROCESSING DEFECT
Aurolab Trust FOCUS PI eye drops recalled for sterility assurance failure
What this means
Aurolab Trust FOCUS PI Hypromellose 0.7% eye drops (a sterile ophthalmic solution) failed to meet sterility standards during manufacturing. Two batches distributed in Virginia are affected. No injuries have been reported.
- Check your eye drops for batch number 6B093FI (expires 04/01/28) or 6F511F1 (expires 05/15/28).
- Stop using the product if you have one of these batches.
- Contact your eye care provider or pharmacist for a replacement or alternative.
- Do not use expired or recalled drops in your eyes.
The agency's original wording
Hazard
Lack of Assurance of Sterility
Intended for
Adults
Illnesses reported
None reported
Sold states
VA
Affected count
25,220 bottles
Manufactured in
1 Sivagangai Main Road, Madurai, India
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0874-2026Want us to check the next one for you?
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