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Verified · FDAClass I — Health RiskMedications

Argatroban Injection, USP, 250 mg/2.5mL , 2.5 mL x 1 Single Dose Vial Recall 2026

ARGATROBANIssued October 13, 2026Updated Reviewed by the Recall Watch editorial team

ARGATROBAN Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Sing — recalled per FDA on 10/13/2026. Reason: Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution..

Agency
FDA
Issued
Oct 13, 2026
Brand
ARGATROBAN
Distribution
1 states
Lots affected
4
What to do right nowHigh risk

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.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued October 13, 2026 · Last synced Nov 2, 2026

What's recalled

Argatroban Injection, USP, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Manufactured for: Endo USA, Malvern,PA 19355/ Argatroban Injection, 250 mg/2.5mL (100 mg/mL), 2.5 mL x 1 Single Dose Vial, Rx only, Distributed by: Par Pharmaceutical, Cranbury, NJ 08512, NDC 42023-182-89.

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Why it was recalled

Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution.

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
Lot #: 84193
Exp Date: 10/2026
92880
Exp Date: 08/2027.
Where was it sold
1 state

Nationwide within the United States

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

Frequently asked questions

Is the ARGATROBAN recall still active?

Yes, this recall is currently active as of October 13, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot #: 84193, Exp Date: 10/2026, 92880, Exp Date: 08/2027.. Check the label on your product.

What should I do if I have the recalled ARGATROBAN?

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