Argatroban Recall: Par Health USA Lot 84193/92880
FDA is recalling Argatroban Injection, USP, 250 mg/2.5 mL, 2.5 mL x 1 single-dose vials, Rx only, distributed nationwide. The recall is due to particulate matter identified in the product solution, including cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material. A total of 1,944 vials are affected; Lot numbers 84193 (exp 10/2026) and 92880 (exp 08/2027) are involved. No corrective action is specified.
| Brand | Par Health USA, LLC |
|---|---|
| Product | 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. |
| Reason | Particulate matter: particulate matter identified as cellulose, polystyrene, polyethylene teraphalate, stainless steel, or stopper material in the product solution. |
| Severity | critical |
| Units affected | 18991 |
| Distribution | Nationwide within the United States |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use Argatroban Injection vials from Lot 84193 or 92880; contact your clinician for guidance.
- Contact the pharmacy or distributor for replacement options and instructions on return/disposal.
- Check your packaging for the lot number and expiration date to confirm whether your vial is affected.
How to identify the recalled item
| Lot / date codes | Lot #: 84193, Exp Date: 10/2026; 92880, Exp Date: 08/2027. |
|---|---|
| Lot / date codes | Lot #: 83449, Exp Date: 10/2026; 82682, Exp Date: 11/2026; 86714, 87302, 87560, Exp Date: 02/2027; 87753, 88401, Exp Date: 03/2027; 88614, 88836, Exp Date: 04/2027; 90220, Exp Date: 05/2027; 91216, 91219, Exp Date: 06/2027; 92004, 92006, Exp Date: 07/2027; 92009, 92596, 92782, 93107, 93329, Exp Date: 08/2027; 93890, Exp Date: 09/2027. |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
Other Par Health USA, LLC recalls
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.