Cefixime Capsules 400 mg Recalled for Failed Impurities and Degradation
Ascend Laboratories recalls Cefixime 400 mg capsules due to failed impurities and degradation specifications. The affected 42,698 bottles were distributed nationwide.
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 involving failed chemical specifications (impurities and degradation). The source text does not report any illnesses, injuries, or hospitalizations, and the hazard is quality-control related rather than a known safety threat. This fits the Moderate category for a Class II recall without reported adverse events.
Plain-English summary
Ascend Laboratories, LLC is recalling Cefixime Capsules, 400 mg, 50-count bottles, distributed nationwide. The recall was initiated due to failed impurities and degradation specifications.
The affected product includes multiple lots with expiration dates ranging from December 2021 through November 2022. The product is manufactured by Alkem Laboratories Ltd. in Mumbai, India, and distributed by Ascend Laboratories, LLC in Parsippany, New Jersey.
Consumers who have purchased this medication should consult their healthcare provider or pharmacist regarding their supply. Patients should not discontinue their antibiotic treatment without medical guidance.
The recalled product
- Product
- CEFIXIME (CEFIXIME)
- Brand
- CEFIXIME
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug — Oral Antibiotic
- Hazard
- failed-impurities-specification
- degradation
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 (15)
- Lot #: 20140293
- Exp Dec 2021
- 20141525
- 20141526
- 20141527
- Exp Mar 2022
- 20143019
- 20143020
- 20143021
- 20143022
- Exp July 2022
- 20144759
- 20144760
- 20144761
- Exp Nov 22
Distribution
Distributed nationwide across the United States.
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