Cephalexin Oral Suspension Recalled for Out-of-Specification Impurity
Ascend Laboratories is recalling 48,936 bottles of Cephalexin oral suspension nationwide due to an out-of-specification impurity (Cephalexin Glucose Adduct) detected during stability testing.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The impurity was discovered as a preventive measure during stability testing before the product could reach patients in a degraded state, making this a precautionary action rather than a response to field reports of harm.
Plain-English summary
Ascend Laboratories, LLC is recalling Cephalexin for Oral Suspension (125 mg per 5 mL) distributed nationwide due to a failed impurities specification detected during stability analysis. During sixth-month stability testing, an out-of-specification result was found in the related substance test, with the impurity identified as Cephalexin Glucose Adduct.
The recall affects 48,936 bottles of 100 mL suspension from the following lots: #23141828 (Exp 5/31/2025), #23141829 (Exp 5/31/2025), #23142342 (Exp 6/30/2025), #23142708 (Exp 7/31/2025), #23144035 (Exp 10/31/2025), #23144270 (Exp 11/30/2025), and #24140026 (Exp 12/31/2025). The product was manufactured by Alkem Laboratories Ltd. in India and distributed under the Ascend Laboratories label.
Patients currently using affected lots should contact their healthcare provider or pharmacist. Do not use affected product without consulting a healthcare professional.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Oral Antibiotic
- Hazard
- impurity
- degradation-product
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 (13)
- Lot #: 23141828
- 23141829
- Exp Date: 5/31/2025
- 23142342
- Exp Date: 6/30/2025
- 23142708
- Exp Date: 7/31/2025
- 23144035
- Exp Date: 10/31/2025
- 23144270
- Exp Date: 11/302025
- 24140026
- Exp Date: 12/31/2025
Distribution
Distributed nationwide across the United States.
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