Drug recall D-0469-2025
Product
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
Reason for recall
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.
Lots and codes
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
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Parsippany, NJ
- Quantity
- 10,620 - 200 mL bottles
- Distribution
- Nationwide in the USA.
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 23, 2025
Related products
- Cephalexin – drug information
- NDC 67877-544 Cephalexin · Cephalexin 125 mg/5mL · Ascend Laboratories, LLC
- NDC 67877-545 Cephalexin · Cephalexin 250 mg/5mL · Ascend Laboratories, LLC