Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is CEPHALEXIN recalled?

The FDA has recorded 7 recalls of CEPHALEXIN (2024–2025) , recalled under brand like CEPHALEXIN. 7 still ongoing.

0
Class I (most serious)
2
Class II
5
Class III
7
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of CEPHALEXIN ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test a 2
Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' ins 2
Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' i 1
Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on t 1
Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Ta 1

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Class II ongoing
Ascend Laboratories, LLC 2025-05-23 lots: 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
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Class II ongoing
Ascend Laboratories, LLC 2025-05-23 lots: 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
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, Class III ongoing
Bryant Ranch Prepack, Inc. 2024-05-10 lots: Lot:234892, Exp:02/28/2025.
Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, U Class III ongoing
Bryant Ranch Prepack, Inc. 2024-05-10 lots: Lot: 235288, 235294, 235368, 235806, 236058, 236138, 236139, 236351, 236490, 236757, 236877, Exp:11/30/2025; 236758, 236762, 237254, 237349, 237401, 237807, Exp: 12/31/2025.
Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP Class III ongoing
Bryant Ranch Prepack, Inc. 2024-05-10 lots: Lot: 235287, 235629, 235805, 236292, 237022, 237308, 237748, Exp: 12/31/2025;
Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP e Class III ongoing
Bryant Ranch Prepack, Inc. 2024-05-10 lots: Lot: 235067, Exp 12/31/2025; 235289, Exp 11/30/2025; 235290, Exp 12/31/2025
Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burba Class III ongoing
Bryant Ranch Prepack, Inc. 2024-05-10 lots: Lot:225541, 226866, 227369, 227519, 229845, 231422, 234889, Exp: 03/31/2025

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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