Ascend Recalls Cephalexin Oral Suspension Due to Impurity Levels
Ascend Laboratories is recalling Cephalexin for Oral Suspension because unidentified impurities were found at higher levels than allowed.
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: The recall is classified as FDA Class II, which typically involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation involving impurities, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Ascend Laboratories LLC is recalling 14,205 bottles of Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 mL. The product is distributed nationwide in the USA. The recall involves specific lots with expiration dates of 9/2021 and 4/2022.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, individual unidentified impurities in the product were found at levels higher than the specification limit. The product is a prescription-only medication manufactured by Alkem Laboratories, Ltd, in India, and distributed by Ascend Laboratories, LLC in Parsippany, NJ.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternatives or replacement.
The recalled product
- Product
- CEPHALEXIN (CEPHALEXIN)
- Brand
- CEPHALEXIN
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Antibiotic
- Hazard
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 (3)
- Lot # 19144841
- Exp 9/2021
- 20141673 Exp 4/2022.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Ascend Laboratories LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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