Class II · Moderate risk
Hydroxocobalamin-Pf- 1mg/Ml
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
B12 Hydroxocobalamin for Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
B12 Hydroxocobalamin for Injection, all strengths and presentations, GenoGenix, LLC, 2840 NW 2nd Ave Ste 204 Boca Raton, FL 33431-6692.
Drug: Hydroxocobalamin
- Recalling firm
- GenoGenix LLC
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0042-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Hydroxocobalamin recalls
See all
Class II · Moderate risk
Dexpanthenol/Pyridoxine/Hydroxocobalamin-PF- 250MG/100MG/1MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Hydroxocobalamin 25MG/ML
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Folic Acid 1 mg/mL Hydroxocobalamin 1 mg/mL
Lack of assurance of sterility.
Class II · Moderate risk
Hydroxocobalamin B12
CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Other recalls by GenoGenix LLC
All 2025 recalls
Class I · High risk
NAD+ (Nicotinamide adenine dinucleotide)
Microbial Contamination of Sterile Products: elevated endotoxin levels
Class II · Moderate risk
Retatrutide for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Tirzepatide
Lack of Assurance of Sterility
Class II · Moderate risk
Semaglutide for Injection
Lack of Assurance of Sterility
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