FDA Recalls Hydroxocobalamin B12 Injection for Manufacturing Control Failures
Olympia Compounding Pharmacy recalls 6,431 vials of Hydroxocobalamin B12 injection nationwide due to manufacturing quality control failures. Environmental and personnel monitoring systems prior to October 2021 did not properly investigate deviations from acceptable limits.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This recall involves a manufacturing control failure affecting a prescription injectable medication. Although no illnesses have been reported, the failure to properly investigate monitoring deviations in a risk-of-harm product represents a potential compromise to product safety, warranting a High severity rating.
Plain-English summary
Olympia Compounding Pharmacy is recalling Hydroxocobalamin B12 1 mg/mL injectable solution in 30 mL multi-dose vials (NDC 73198-0080-30). Approximately 6,431 vials have been distributed nationwide across four lot codes: D48026 (BUD 4/26/2022), E48025 (BUD 5/25/2022), G48B21 (BUD 7/21/2022), and G48C21 (BUD 7/21/2022).
The FDA initiated this recall due to Current Good Manufacturing Practice violations. Prior to October 1, 2021, the manufacturer did not properly investigate excursions in environmental and personnel monitoring systems—instances when measured values exceeded acceptable limits. These quality control measures are required to ensure drug safety and effectiveness.
No illnesses or injuries associated with this recall have been reported. Individuals or healthcare providers with vials from the affected lots should consult their pharmacy regarding the recall for further guidance.
The recalled product
- Product
- Hydroxocobalamin B12, 1 mg/mL, 30 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0080-30.
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable medication
- Hazard
- cgmp-violation
- quality-control-failure
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 (4)
- Lots: D48026 BUD: 4/26/2022
- E48025 BUD: 5/25/2022
- G48B21 BUD: 7/21/2022
- G48C21 BUD: 7/21/2022
Distribution
Distributed nationwide across the United States.
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