Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Cyanocobalamin recalled?

Yes — there is an active recall. 19 ongoing FDA recalls mention Cyanocobalamin (75 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Cyanocobalamin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Cyanocobalamin recalls on record

none so far in 2026; 75 on record, newest first
Class II · Moderate risk

Cyanocobalamin 1

Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility

Terminated Sterility / contamination The Compounding Pharmacy of America D-1457-2015
Class II · Moderate risk

Cyanocobalamin 2000mcg/1ml 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.

Terminated Sterility / contamination Health Innovations Pharmacy, Inc D-1000-2015
Class II · Moderate risk

Cyanocobalamin active pharmaceutical ingredient packaged in…

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.

Terminated Cross-contamination Attix Pharmaceuticals D-604-2015
Class II · Moderate risk

Cyanocobalamin 1000 mcg/mL injectable solution 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.

Terminated Sterility / contamination Martin Avenue Pharmacy, Inc. D-0072-2015
Class II · Moderate risk

Vitamin B12 Cyanocobalamin 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

Terminated Unapproved drug Medical Supply Liquidators Llc D-1522-2014
Class II · Moderate risk

Lipotropic Gold

Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.

Terminated Sterility / contamination John W Hollis Inc D-1404-2014
Class II · Moderate risk

Cyanocobalamin 100mcg/ml injection

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.

Terminated Sterility / contamination Natures Pharmacy & Compounding Center D-1103-2014
Class II · Moderate risk

Cyanocobalamin

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.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-415-2014
Class II · Moderate risk

Cyanocobalamin 1000 Mcg/Ml Inj Soln

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Terminated Sterility / contamination Beacon Hill Medical Pharmacy, P.C. D-946-2013
Class II · Moderate risk

Cyanocobalamin

Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 1000 mcg may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 50 mg, NDC 40985022251, Pedigree: AD30180_19, EXP: 5/9/2014; COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: AD37056_4, EXP: 5/10/2014. VITAMIN B COMPLEX PROLONGED RELEASE, Tablet, 0, NDC 40985022251, Pedigree: AD7362

Terminated Labeling / mix-up Aidapak Services, LLC D-933-2014
Class II · Moderate risk

Cyanocobalamin

Labeling: Label Mixup:CYANOCOBALAMIN, Tablet, 500 mcg was mislabled as SEVELAMER CARBONATE, Tablet, 800 mg, NDC 58468013001, Pedigree: W002859, EXP: 6/7/2014. and may have potentially been mislabeled as one of the following drugs: VITAMIN B COMPLEX W/C, Tablet, 0, NDC 00536730001, Pedigree: AD52993_7, EXP: 5/20/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00536355601, Pedigree: AD30180_22, EXP:

Terminated Labeling / mix-up Aidapak Services, LLC D-932-2014
Class II · Moderate risk

Cyanocobalamin

Labeling: Label Mixup: CYANOCOBALAMIN, Tablet, 100 mcg may have potentially been mislabeled as the following drug: guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_7, EXP: 5/24/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-931-2014
Class II · Moderate risk

Cyanocobalamin

Labeling: Label Mixup; CYANOCOBALAMIN, Tablet, 1000 mcg may be potentially mislabeled as VITAMIN B COMPLEX W/C, Tablet, NDC 00904026013, Pedigree: AD21846_43, EXP: 5/1/2014; NIACIN TR, Capsule, 500 mg, NDC 00904063160, Pedigree: AD46257_22, EXP: 5/15/2014; chlorproMAZINE HCl, Tablet, 50 mg, NDC 00832030200, Pedigree: AD32973_4, EXP: 5/9/2014; PRENATAL MULTIVITAMIN/MULTIMINERAL, Tablet, NDC

Terminated Labeling / mix-up Aidapak Services, LLC D-466-2014
Class II · Moderate risk

Cyanocobalamin

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination Axium Healthcare Pharmacy dba Balanced Solutions Compounding D-275-2013
Class II · Moderate risk

Cyanocobalamin Injection

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Terminated Sterility / contamination FVS Holdings, Inc. dba. Green Valley Drugs D-355-2013
Class II · Moderate risk

Medi-bolic Booster Injectable

CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.

Terminated cGMP deviation RX South LLC DBA RX3 Pharmacy D-191-2013
Class I · High risk

Cyanocobalamin 1000 mcg/ml

Non-Sterility: Green Valley Drugs received positive sterility results from their testing lab on two lots of Methylprednisolone Preservative Free 40 mg/mL injectable suspension and one lot of Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV.

Terminated Sterility / contamination Green Valley Drugs D-322-2013
Class II · Moderate risk

Cyanocobalamin

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1488-2012