Cyanocobalamin Injection Recalled for Subpotent Drug - Out of Specification Assay
Aurobindo Pharma USA Inc. is recalling 433,809 vials of Cyanocobalamin injection nationwide because assay testing showed the drug is subpotent, containing less than the specified 1,000 mcg/mL of active ingredient. Affected lots with specific expiration dates from September 2022 to April 2023 are identified for recall.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class III recall of a subpotent drug with no reported illnesses or injuries. According to the severity rubric, Class III recalls are typically scored 1-2; this is a manufacturing/quality defect rather than an acute safety hazard, warranting a Moderate (2) severity score.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Cyanocobalamin (Vitamin B12) Injection, USP, 1,000 mcg/mL, across the United States. The recall affects 433,809 vials distributed nationwide. Specific lot numbers with expiration dates from September 2022 through April 2023 are included in this recall.
The recall was initiated because quality control testing found that the drug is subpotent, containing less than the specified 1,000 mcg/mL of cyanocobalamin per mL. This out-of-specification assay result was identified during manufacturing quality testing.
Healthcare providers should check medication records for patients who may have received affected lots. Patients with questions about their treatment should contact their healthcare provider or pharmacist. No illnesses or injuries related to this product have been reported to the FDA.
The recalled product
- Product
- CYANOCOBALAMIN (CYANOCOBALAMIN)
- Brand
- CYANOCOBALAMIN
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Injectable Vitamin B12
- Affected units
- 433,809
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (9)
- Lots: CCC210004
- Exp 09/2022
- CCC210005
- CCC210006
- CCC210007
- Exp 11/2022
- CCC210010
- CCC210011
- Exp 04/2023.
UPCs (2)
- 0355150364015
- 0355150364107
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · CYANOCOBALAMIN
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- SevereAmerican Regent Recalls Cyanocobalamin Injections Due to Particulate Matter
FDA (Drugs) · 2026-08-26
- ModerateCardinal Health Recalls Cyanocobalamin Injection Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- SevereFresenius Kabi Recalls Cyanocobalamin Vials Due to Sterility Concerns
FDA (Drugs) · 2014-12-17
Same manufacturer · Aurobindo Pharma USA Inc.
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateAmazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
FDA (Drugs) · 2025-06-25
- HighPrescription drug recall: Aurobindo Nebivolol tablets contain excess nitrosamine impurity
FDA (Drugs) · 2024-12-25
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighFDA Recalls Cinacalcet 30mg Tablets for N-nitroso Impurity
FDA (Drugs) · 2024-12-11
Same hazard · subpotent
See all →- ModerateCAREone Earwax Removal Drops Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22
- HighCompounded vasopressin syringes recalled as subpotent by IntegraDose Compounding Services
FDA (Drugs) · 2026-06-24
- ModerateSkin Rehab calming hydrocortisone balm recalled as a subpotent drug
FDA (Drugs) · 2026-04-22
- Moderateglo Skin Beauty Remedy Gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22
- ModerateRhonda Allison calming skin gel recalled as a subpotent hydrocortisone product
FDA (Drugs) · 2026-04-22