CLASS II Drug recall · Reported 2 Oct 2024 · FDA Enforcement Report
Pyridoxine HCL (B6) Injection Solution recalled by Empower Pharmacy
Empower Pharmacy is recalling Pyridoxine HCL (B6) Injection Solution, 100mg/mL Sterile Multiple-Dose Vial, For IM or IV, distributed nationwide in the US. The recall was initiated on 5 Sep 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0663-2024
- FDA event ID
- 95304
- Recalling firm
- Empower Pharmacy, Houston, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Sep 2024
- FDA classified
- 20 Sep 2024
- Reported
- 2 Oct 2024
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 5 Sep 2024 | Recall initiated by company | |
| 20 Sep 2024 | Classified by FDA | +15 days |
| 2 Oct 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Pyridoxine HCL (B6) Injection Solution, 100mg/mL, 30 mL Sterile Multiple-Dose Vial, For IM or IV use only, RX Only, Compounded by: Empower Pharmacy 5980 W Sam Houston Pkwy N Ste 300, Houston, TX 77041 NDC 72627-2424-1.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
Product lot number: 609763 Beyond Use Date: 04/18/2025
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Pyridoxine (b6 recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pyridoxine HCL (B6) 100MG/ML MDV, Red Mountain Compounding Rx recalled | First Royal Care Co. LLC | Sterility | 7 states |