Recalls / Class II
Class IID-0468-2025
Product
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
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDCs
- 67877-544, 67877-545
- FDA application
- ANDA210221
- Affected lot / code info
- 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
Why it was recalled
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.
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 48,936 - 100 mL bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2025-05-23
- FDA classified
- 2025-06-12
- Posted by FDA
- 2025-06-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0468-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.