Cefuroxime 4mg /0.4 mL
Lack of Assurance of Sterility
Yes — there is an active recall. 1 ongoing FDA recall mention Cefuroxime (8 total). Check the affected lots below.
Most common reason: Sterility / contamination (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Cefuroxime. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of Assurance of Sterility
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of Assurance of Sterility
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper
Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date.
Lack of Assurance of Sterility; all compounded products within expiry produced using recalled filters
Lack of sterility assurance.
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