Cephalexin: 16 recalls on record

Recalled by 1 agency: FDA (16).

First recall on record: February 6, 2019. Most recent: June 18, 2025.

Risk classification: Class II: 11 · Class III: 5

Most recent recalls

DateAgencyProduct
June 18, 2025FDACephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manuf…D-0469-2025
June 18, 2025FDACephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manuf…D-0468-2025
June 12, 2024FDACephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each con…D-0537-2024
June 12, 2024FDACephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contain…D-0540-2024
June 12, 2024FDACephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contai…D-0538-2024
June 12, 2024FDACephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each con…D-0539-2024
June 12, 2024FDACephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: B…D-0536-2024
May 5, 2021FDACephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 …D-0342-2021
February 24, 2021FDACephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufact…D-0264-2021
February 24, 2021FDACephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufac…D-0263-2021
January 13, 2021FDACephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) …D-0185-2021
January 6, 2021FDAAscend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when…D-0179-2021
September 16, 2020FDACephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Onl…D-1566-2020
September 16, 2020FDACephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Onl…D-0012-2021
September 16, 2020FDACephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Onl…D-0013-2021
February 6, 2019FDACephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmace…D-0423-2019

Questions about this brand

How many recalls does Cephalexin have?
Recalert has 16 U.S. recalls on record for Cephalexin, published between February 6, 2019 and June 18, 2025.
What was the most recent Cephalexin recall?
FDA recall D-0469-2025, published June 18, 2025: 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, ND…
Which agencies have recalled Cephalexin products?
Cephalexin products appear in recalls from: FDA (16).

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