FDA Recall D-0469-2025

Ascend Laboratories, LLC · Parsippany, NJ

Class II Ongoing 356 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68

Lot / code: 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

Quantity: 10,620 - 200 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.

Recall record

Recall number: D-0469-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA.
Recall initiated: 2025-05-23
Classified by FDA Center: 2025-06-12
FDA published: 2025-06-18
Recalling firm: Ascend Laboratories, LLC
Firm location: Parsippany, NJ

Drug identification

Brand name(s): CEPHALEXIN
Generic name(s): CEPHALEXIN
Manufacturer(s): Ascend Laboratories, LLC
NDC(s): 67877-544, 67877-545
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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