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Ongoing FDAEvent 99449 (2 months ago)

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections contain particulate matter.

Moderate risk

Taking it may cause temporary or medically reversible health problems. Serious harm is unlikely.

FDA Class II recall · How risk is rated

2 photos

What to do

What happened

Fresenius Kabi USA, LLC, of Lake Zurich, Illinois, recalled five injectable products because hair was found in the products. The products are Naropin (ropivacaine hydrochloride Injection, USP), Xylocaine (lidocaine HCl Injection, USP), Lidocaine HCl Injection, USP, and Glycopyrrolate Injection, USP. The recall began July 16, 2026, and was added to the FDA's Enforcement Report on July 23, 2026. Distribution was nationwide within the USA.

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:

  1. Check the FDA or company notice for instructions specific to this product.
  2. Ask your pharmacist or doctor whether your lot is affected and what to do.

Is yours affected?

Match the list below, then check the codes the FDA notice also names.

  1. Naropin (ropivacaine hydrochloride Injection, USP), 0.5%

    Reason: Presence of Particulate Matter: Hair was found in products

    Strength
    100 mg
    Lot
    • 6133436
  2. Xylocaine (lidocaine HCl Injection, USP), 1%

    Reason: Presence of Particulate Matter: Hair was found in products

    1. Strength
      200 mg
      Lot
      • 6130235
    2. Strength
      500 mg
      Lot
      • 6133986
  3. Lidocaine HCl Injection, USP, 2%

    Reason: Presence of Particulate Matter: Hair was found in products

    Strength
    100 mg
    Lot
    • 6133801
  4. Glycopyrrolate Injection, USP

    Reason: Presence of Particulate Matter: Hair was found in product

    Strength
    1 mg
    Lot
    • 6134349
    • 6134620

From the FDA notice

NDC Tray: 63323-578-05; NDC Vial: 63323-578-07

Details

Company began the recall
Sold in

Nationwide within in the USA

Event ID
99449
Recall numbers
D-0725-2026 to D-0729-2026
Company
Fresenius Kabi USA, LLCLake Zurich, Illinois
Recall type
Voluntary: Firm initiated
Customers told by
Letter
  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

All recalls from Fresenius Kabi USA, LLC

Summary by Recall Canary, written with AI · summary updated Oct 10, 2026 · primary source: U.S. Food and Drug Administration