Cephalexin Oral Suspension Recalled for Chemical Impurity
Cephalexin oral suspension is being recalled due to a chemical impurity found during quality testing. Multiple lots distributed nationwide are affected.
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 without reported illnesses or injuries. The recall is based on a chemical specification failure identified during stability testing, constituting a voluntary precautionary recall rather than a confirmed hazard.
Plain-English summary
Ascend Laboratories, LLC is recalling Cephalexin for Oral Suspension, USP (125 mg per 5 mL), manufactured by Alkem Laboratories Ltd. and distributed by Ascend Laboratories. The recall affects 10,620 bottles (200 mL when mixed) that were distributed nationwide.
During stability analysis at the sixth-month testing point, results from the related substance test exceeded acceptable specifications. A chemical impurity, identified as Cephalexin Glucose Adduct, was detected at out-of-specification levels.
The recalled product has multiple lot numbers with expiration dates ranging from June 2025 through October 2026. Patients currently taking this medication should consult their healthcare provider or pharmacist to determine if their prescription is affected. For additional information, contact Ascend Laboratories.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Antibiotic
- Hazard
- chemical-impurity
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 (12)
- 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
Distribution
Distributed nationwide across the United States.
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