Class II · Moderate risk
B12 Hydroxocobalamin for Injection
Lack of Assurance of Sterility
Is Hydroxocobalamin recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Hydroxocobalamin (67 total). Check the affected lots below.
Most common reason: Sterility / contamination (54 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroxocobalamin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydroxocobalamin recalls on record
none so far in 2026; 67 on record, newest first
Class II · Moderate risk
Hydroxocobalamin-Pf- 1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin 25MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Hydroxocobalamin B12
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class III · Low risk
Hydroxocobalamin B12 1mg/mL
Sub Potent
Class II · Moderate risk
Hydroxocobalamin Preservative Free 5mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 25mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Mic B Complex With Hydroxocobalamin 5mg/Ml Inj Injectable
Lack of assurance of sterility
Class II · Moderate risk
Hydroxocobalamin 5
Lack of assurance of sterility
Class II · Moderate risk
Hydroxocobalamin 1
Lack of assurance of sterility
Class II · Moderate risk
Hydroxocobalamin Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Vitamin B1/B2/B3/B6/HYDROXOCOBALAMIN 66/1.33/66/66/0.66 mg/mL
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 30 mg/30 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 10 mg/20 mL
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 10 mL Vial 5 mg/10 mL
Lack of Assurance of Sterility
Class II · Moderate risk
S-Hydroxocobalamin 1000mcg/Ml Mdv Inj
Lack of Assurance of Sterility
Class II · Moderate risk
S-Hydroxocobalamin 10mg/Ml Mdv Inj Sol
Lack of Assurance of Sterility
Class II · Moderate risk
C-Hydroxocobalamin 25 Mg/Ml Injection Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
C-Hydroxocobalamin 5 Mg/Ml Injection Solution
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Hydroxocobalamin 10 mg/mL Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Hydroxocobalamin 1000 Mcg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 1000 Mcg/Ml
Lack of Assurance of Sterility
Class II · Moderate risk
Lipoplex
Lack of assurance of sterility for injectables and solutions intended to be sterile.
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