Class II · Moderate risk
Hcg 5
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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
Hcg 5
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hcg 2
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hcg 1
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hcg 1
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hcg 1
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hcg 1
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Methylcobalamin/B-Complex Rx 2.5/103 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin/Hydroxocobalamin Rx 3.125/3.125 mg/0.5 mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin 1000 mcg/mL Injection
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Methylcobalamin
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
Methylcobalamin 25 mg/mL injectable packaged in an amber glass injectable vial
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
Methylcobalamin 10 mg/mL injectable packaged in an amber glass injectable vial
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
Methylcobalamin
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
Methylcobalamin 1 mg/mL injectable packaged in an amber glass injectable vial
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
B Complex for Injection USP with Methylcobalamin 1000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Super MIC B Complex for L-Carnitine for Injection USP with Methylcobalamin 1000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Vitamin B12 Methylcobalamin 5000 Injection USP 5000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Vitamin B12 Methylcobalamin Injection USP 1000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
Vitamin B12 Methylcobalamin with MIC Injection USP 1000 mcg/ml
Marketed without an Approved NDA/ANDA; IM and SQ injectable products are being recalled because the manufacturing firm is not registered with the FDA as a drug manufacturer
Class II · Moderate risk
HCG (Human Chorionic Gonadotropin)
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Class II · Moderate risk
Methylcobalamin for Intramuscular Or Subcutaneous Use Only
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Class II · Moderate risk
Methylcobalamin
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
METHYLCOBALAMIN * 10 mg/mL INJECTABLE
Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.
Class II · Moderate risk
Methylcobalamin Injection 5 mg/mL
Lack of Assurance of Sterility: Park Compounding is recalling Methylcobalamin 5 mg/mL, Multitrace-5 Concentrate, and Testosterone Cypionate (sesame oil) for injection due to lack of sterility assurance.
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