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Verified · FDAClass II — Possible RiskMedications

FOCUS PI Hypromellose 0.7% Formula, 0.3 FL O per vial, STERILE, Manufactured Recall 2026

FOCUS PIIssued September 17, 2026Updated Reviewed by the Recall Watch editorial team

FOCUS PI 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 — recalled per FDA on 9/17/2026. Reason: Lack of Assurance of Sterility.

Agency
FDA
Issued
Sep 17, 2026
Brand
FOCUS PI
Distribution
1 states
Lots affected
4
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

Verified summary of the official U.S. Food and Drug Administration notice · Issued September 17, 2026 · Last synced Oct 14, 2026

What's recalled

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

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Why it was recalled

Lack of Assurance of Sterility

Affected products & lot numbers
4 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Batch# 6B093FI
Exp. 04/01/28
Batch# 6F511F1
Exp. 05/15/28
Where was it sold
1 state

VA

nationwide
Official noticefda.gov
More recalls like this
4 related — by brand, contaminant, and category

Frequently asked questions

Is the FOCUS PI recall still active?

Yes, this recall is currently active as of September 17, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Batch# 6B093FI, Exp. 04/01/28, Batch# 6F511F1, Exp. 05/15/28. Check the label on your product.

What should I do if I have the recalled FOCUS PI?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.