Class II · Moderate risk
Methylcobalamin/Hydroxocobalamin Preservative Free Unit Dose Syringes
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Is Methylcobalamin recalled?
Yes — there is an active recall. 24 ongoing FDA recalls mention Methylcobalamin (176 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methylcobalamin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Methylcobalamin recalls on record
none so far in 2026; 176 on record, newest first
Class II · Moderate risk
Methylcobalamin Preservative Free Prefilled
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Preservative Free Prefilled
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Mdv
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Mdv
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin Mdv
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Methylcobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxycobalamine/Methylcobalamine Pf Unit Dose
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Chorionic Gonadotropin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
S-Methylcobalamin 5000 mcg/mL Inj.
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
S-methylcobalamin 25 mg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
S-Methylcobalamin 1000 mcg/mL
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
Methylcobalamin 1
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Methylcobalamin 5000 mcg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility: Aluminum crimps do not fully seal the rubber stopper to the vials.
Class II · Moderate risk
MIC+Methylcobalamin 4000 mcg/ml Injection
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 7.5 mg/ml + Methionine 25 mg/ml + Inositol 50…
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 1
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 10 mg/ml + 5 Methyl Tetrahydrofolate 4 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 25
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 5
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 4
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 10
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin 1
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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