Class II · Moderate risk
Kit for the Preparation of Technetium Tc 99m Sestamibi Injection
Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product
Is Mannitol recalled?
Not under an active recall.
Mannitol was recalled 31 times in the past — all now closed. Most recent: Nov 26, 2024.
Most common reason: Sterility / contamination (18 of these recalls)
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
Cardioplegia Solution del Nido Formula
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Cardioplegia Solution del Nido Formula
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class III · Low risk
NETSPOT (kit for the preparation of Ga 68 dotatate injection)
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Class II · Moderate risk
Sincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg
Super Potent and Failed Reconstitution Time
Class III · Low risk
Sb-4
Sub Potent
Class III · Low risk
T-105
Super Potent
Class III · Low risk
Formula F9
Sub Potent
Class II · Moderate risk
NAD+ Nicotinamide Adenine Dinucleotide
Product found to be Sub Potent or Exceeded reconstitution time
Class II · Moderate risk
Class II · Moderate risk
Human Chorionic Gonadotropin 1
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 5
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 6
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Human Chorionic Gonadotropin 11
CGMP deviations: Lack of potency testing.
Class II · Moderate risk
Sodium Chloride 0.9% 1 LITER WITH Potassium Chloride 20 mEq
Lack of Assurance of Sterility
Class II · Moderate risk
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Lack of Assurance of Sterility
Class II · Moderate risk
Cisplatin 40 MG / 500 ml NS IVPB WITH Mannitol 40 G
Lack of Assurance of Sterility
Class II · Moderate risk
DelNido Cardioplegia
Lack of sterility assurance.
Class II · Moderate risk
Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder
Lack of Assurance of Sterility
Class II · Moderate risk
Sermorelin/GHRP-2/GHRP-6 Mannitol 9 mg/9 mg/9 mg/300 mg Powder
Lack of Assurance of Sterility
Class II · Moderate risk
HCG 6000 unit/0.3 gm Mannitol Lyopholized 6000 IU/vial injectable
Lack of Assurance of Sterility
Class II · Moderate risk
Hcg 50
Lack of Assurance of Sterility
Class II · Moderate risk
Hcg 10
Lack of Assurance of Sterility
Class II · Moderate risk
Mannitol 20%
Lack of Assurance of Sterility.
Class II · Moderate risk
Mannitol I.V.
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
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