FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per… was recalled on September 17, 2026 in cooperation with the U.S. Food and Drug Administration because lack of Assurance of Sterility.
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# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28
Units affected: 25,220 bottles
Where it was sold: VA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Lack of Assurance of Sterility
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Aurolab Trust
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed dissolution specifications.
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