Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Cefepime recalled?

Yes — there is an active recall. 3 ongoing FDA recalls mention Cefepime (19 total). Check the affected lots below.

Most common reason: Sterility / contamination (17 of these recalls)

Recalls are matched by product description. A recall usually affects specific lots, not every package of Cefepime. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Cefepime recalls on record

none so far in 2026; 19 on record, newest first
Class II · Moderate risk

Cefepime

Lack of Assurance of Sterility: Product sterility cannot be guaranteed.

Terminated Sterility / contamination Sentara Enterprises D-0629-2016
Class II · Moderate risk

Cefepime HCl

Lack of Assurance of Sterility: Sterility of product is not assured.

Terminated Sterility / contamination Lincare, Inc. D-1199-2015
Class II · Moderate risk

Cefepime 2 gm/100 mL 0.9%NS

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1481-2014
Class II · Moderate risk

Cefepime 1 gm/100 mL 0.9%NS

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1479-2014
Class II · Moderate risk

Cefepime 2 gm/100 mL D5W

Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within expiry are subject to this recall. This recall is initiated due to concerns associated with quality control procedures observed during a recent FDA inspection.

Ongoing Sterility / contamination Franck's Lab Inc dba Trinity Care Solutions D-1457-2014