Cyanocobalamin Injection
Subpotent Drug: Out of specification for assay.
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.
Subpotent Drug: Out of specification for assay.
Subpotent Drug: Out of Specification results for Assay
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
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.
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
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