Pyridoxine Injection Solution Recalled Due to Lack of Sterility Assurance
Empower Pharmacy is recalling a pyridoxine (B6) injection solution because sterility assurance could not be confirmed. The recalled product is lot 609763 with a beyond-use date of 04/18/2025.
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 is an FDA Class II recall of a sterile injectable medication where sterility assurance cannot be confirmed. Although no illnesses or injuries have been reported, non-sterile injectable solutions pose a serious risk of infection and meet the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Empower Pharmacy has recalled a compounded pyridoxine HCL (Vitamin B6) injection solution (100 mg/mL, 30 mL sterile multiple-dose vials) due to lack of assurance of sterility. The recall affects approximately 450 vials of lot number 609763 with a beyond-use date of 04/18/2025 that were distributed nationwide.
Pyridoxine is a vitamin B6 supplement administered by intramuscular or intravenous injection. Non-sterile injectable medications pose a risk of serious bacterial infection. Because sterility assurance could not be confirmed for the recalled lot, patients who received injections from these vials may have received non-sterile product.
Patients who received an injection from a recalled vial should contact their healthcare provider. Healthcare providers should inform patients and monitor them for signs of infection, including fever, redness or swelling at the injection site, or other symptoms of infection. Consumers should not use vials from lot 609763. The product was compounded by Empower Pharmacy, 5980 W Sam Houston Parkway North, Suite 300, Houston, TX 77041.
The recalled product
- Product
- 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.
- Manufacturer
- Empower Pharmacy
- Hazard
- lack-of-sterility
- bacterial-contamination
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 (1)
- Product lot number: 609763 Beyond Use Date: 04/18/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27