FOCUS PI Hypromellose 0.7% Formula
FOCUS PI Hypromellose 0.7% Formula lacks assurance of sterility.
Moderate risk
Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Aurolab Trust recalled FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O (10 mL) per vial, STERILE, due to lack of assurance of sterility. The product was manufactured for Covalent Management, Inc., Manassas, VA 20109. The recall began September 17, 2026, and was added to the FDA's Enforcement Report on September 28, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Focus PI Hypromellose 0.7% Formula
- NDC
- 82724-007-19
- Lot
- 6B093FI
- 6F511F1
Details
- Company began the recall
- Sold in
- Event ID
- 99903
- Recall No.
- D-0874-2026
- Company
- Aurolab TrustMadurai, India
- Hazard
- Sterility failure
- Quantity recalled
- 25,220 bottles
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
Summary updated
In FDA's weekly enforcement report
