Ascend Laboratories, LLC: Drug Recall
Recall #D-0468-2025 · 05/23/2025
Class II: Risk
Recall Details
- Recall Number
- D-0468-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ascend Laboratories, LLC
- Status
- Ongoing
- Date Initiated
- 05/23/2025
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 48,936 - 100 mL bottles
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.
Product Description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88
Distribution Pattern
Nationwide in the USA.
Other Recalls by Ascend Laboratories, LLC
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 08/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.