Class II · Moderate risk
HYDROXOCOBALAMIN Injectable-30 mL MDV. Coastal Meds LLC 1759 Medical Park Dr.
Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Is Hydroxocobalamin recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Hydroxocobalamin (67 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroxocobalamin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydroxocobalamin recalls on record
none so far in 2026; 67 on record, newest first
Class II · Moderate risk
Hydroxocobalamin 1 mg/mL 30 mL Vial For IM Use
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Hydroxocobalamin 0.5 mg/mL For Diluent Purpose Only 10 mL Vial
Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk
Hydroxocobalamin 1mg Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 5000IU/mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 1mg/mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxocobalamin 20 mg/mL Injection
Lack of assurance of sterility
Class II · Moderate risk
Methylcobalamin/Hydroxocobalamin Preservative Free Unit Dose Syringes
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin Multidose Vial
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
Hydroxocobalamin
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
Hydroxocobalamin
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
HYDROXOCOBALAMIN Injection
Penicillin Cross Contamination: potentially contaminated with penicillin
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
Hydroxocobalamin 10 mg/ml Folic Acid 4 mg/ml Injectable
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydroxocobalamin 5
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydroxocobalamin 10
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydroxocobalamin 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
Chorionic Gonadotropin/ Hydroxocobalamin Lyophilized Powder Injectable
Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.
Class II · Moderate risk
Hydroxocobalamin 1) 1000mcg/mL
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
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