US Drug Recall Register

Is Mannitol recalled?

Not under an active recall. Mannitol was recalled 31 times in the past — all now closed. Most recent: Nov 26, 2024.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Mannitol. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.

Class II · Moderate risk Terminated

Mannitol 5% Injectable

Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

The Compounding Pharmacy of America D-1566-2015
Class II · Moderate risk Terminated

Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0118-2015
Class II · Moderate risk Terminated

Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar

Reason Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.

Martin Avenue Pharmacy, Inc. D-0070-2015
Class II · Moderate risk Terminated

Mannitol 5% Solution for injection

Reason Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

John W Hollis Inc D-1394-2014
Class II · Moderate risk Terminated

Mitomycin/Mannitol

Reason The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.

Main Street Family Pharmacy, LLC D-251-2014
Class II · Moderate risk Terminated

Mannitol 20% Injectable 1250 Ml 250 Ml 2500 Ml 400 Ml

Reason Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1569-2012