Class IIDrug
Focus PI Hypromellose 0.7% Formula recall
Summary
Aurolab Trust is recalling FOCUS PI Hypromellose 0.7% Formula (drug). According to the FDA report, the reason is: Lack of Assurance of Sterility. The FDA rated this a Class II: the product may cause temporary or medically reversible health problems; serious harm is unlikely. Recall status: Ongoing.
Details from the FDA report
- 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
- Reason
- Lack of Assurance of Sterility
- Lot / code info
- Batch# 6B093FI, Exp. 04/01/28; Batch# 6F511F1, Exp. 05/15/28
- Quantity
- 25,220 bottles
- Distribution
- VA
- Recalling company
- Aurolab Trust, Madurai, India
- Recall started
- September 17, 2026
- FDA report date
- October 7, 2026
- Classification
- Class II: The product may cause temporary or medically reversible health problems; serious harm is unlikely.
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0874-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Aurolab Trust) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.