FDAFDA · Food and drugs·Recall number D-0469-2025
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
Published June 18, 2025 · Recall initiated: May 23, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- Nationwide in the USA.
- Lot
- Lot #: 23142343, Exp Date: 6/30/2025; 23143526, Exp Date: 9/30/2025; 23144036, Exp Date: 10/31/2025; 23144269, Exp Date: 11/30/2025; Lot 24140027, Exp Date: 12/31/2025; 24144282, Exp Date: 10/31/2026
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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