Class I · High risk
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Is Heparin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Heparin (118 total). Check the affected lots below.
Most common reason: Sterility / contamination (92 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Heparin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Heparin recalls on record
none so far in 2026; 118 on record, newest first
Class II · Moderate risk
heparin added to 0.9% sodium chloride
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
heparin 7500 units added to 0.9% sodium chloride 1000mL
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
Neonatal TPN Starter Bag
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk
heparin 5000 units/500mL added to 0.9% sodium chloride
Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
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