Class II · Moderate risk
Mannitol 5% Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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. Checked against openFDA on Oct 10, 2026.
Mannitol recalls on record
none so far in 2026; 31 on record, newest first
Class II · Moderate risk
Phentolamine mesylate 5 mg/35 mg/mannitol trituration packaged in a white jar
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.
Class II · Moderate risk
Chorionic gonadotropin/mannitol 10000 U/0.1 gm powder packaged in a white jar
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.
Class II · Moderate risk
Mannitol 5% Solution for injection
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Mitomycin/Mannitol
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.
Class II · Moderate risk
Mannitol 20% Injectable 1250 Ml 250 Ml 2500 Ml 400 Ml
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.
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