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Prescription medicine · generic available

Cephalexin

Full FDA label All drugs

Official FDA data, not advice

Everything here comes from the U.S. Food and Drug Administration (FDA): the drug label, the NDC Directory, Drugs@FDA, recall reports and the drug shortage list. Each fact shows its source and date.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

In an emergency, call 911. If someone may have taken too much of a medicine, call Poison Help: 1‑800‑222‑1222.

At a glance

NoBoxed warning
None listedFDA shortage list
17Recalls (FDA reports)
29Companies
1987First FDA approval on file

Quick answers

What is Cephalexin used for?
The FDA-approved label (Cephalexin, PD-Rx Pharmaceuticals, Inc., September 14, 2026) says: “Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection Otitis media Skin and skin structure infections Bone infections Genitourinary tract infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Cephalexin have a boxed warning?
No. None of the 139 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Cephalexin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Cephalexin been recalled?
FDA enforcement reports list 17 recalls of products of this medicine; the newest started May 23, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Cephalexin?
29 companies list prescription products of Cephalexin in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and NuCare Pharmaceuticals, Inc..

What Cephalexin is used for

Quoted from the “Indications and Usage” section of the FDA-approved label.

Cephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection Otitis media Skin and skin structure infections Bone infections Genitourinary tract infections To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin and other antibacterial drugs …

— FDA label: Cephalexin, PD-Rx Pharmaceuticals, Inc., effective September 14, 2026. Read the full label on DailyMed →

The FDA has 139 labels for products of this medicine (different makers and forms); uses can differ between them. Check the label that comes with your own medicine.

This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.

Boxed warning

A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.

The label quoted above has no boxed warning.

0 of 139 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · For suspension · Powder, for suspension · Tablet · Tablet, film coated
RouteOral
Prescription products182 in the FDA NDC Directory

What pharmacies pay (NADAC)

The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.

This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.

NADAC per unit for Cephalexin, by strength and form
Strength and formGeneric or brandPharmacies pay
cephalexin 125 mg/5 mL
for suspension		 Generic $0.0430–$0.0759 per mL
4 packages, lowest to highest
cephalexin 125 mg/5 mL
powder, for suspension		 Generic $0.0430–$0.0759 per mL
6 packages, lowest to highest
cephalexin 250 mg
capsule		 Generic $0.0901 per capsule
cephalexin 250 mg
tablet		 Generic $0.7167 per tablet
cephalexin 250 mg
tablet, film coated		 Generic $0.7167 per tablet
cephalexin 250 mg/5 mL
for suspension		 Generic $0.0488–$0.0683 per mL
4 packages, lowest to highest
cephalexin 250 mg/5 mL
powder, for suspension		 Generic $0.0488–$0.0683 per mL
6 packages, lowest to highest
cephalexin 500 mg
capsule		 Generic $0.1168 per capsule
cephalexin 500 mg
tablet		 Generic $1.31 per tablet
cephalexin 500 mg
tablet, film coated		 Generic $1.31 per tablet
cephalexin 750 mg
capsule		 Generic $5.27 per capsule

NADAC list of November 4, 2026; these prices took effect on October 21, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.

Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →

Companies that list this medicine

Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.

FDA approval history

  • ANDA: Abbreviated New Drug Application: how a generic version is approved.

Generic approvals (14)

Shortage status

The FDA drug shortage list does not show these products.

FDA Drug Shortages database →

Recalls

From FDA enforcement reports, matched by the product’s NDC code. A recall usually covers specific lots only: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.

  1. May 23, 2025 · Class II · Ongoing · D-0469-2025

    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.

    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 — Ascend Laboratories, LLC

  2. May 23, 2025 · Class II · Ongoing · D-0468-2025

    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.

    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 — Ascend Laboratories, LLC

  3. May 10, 2024 · Class III · Ongoing · D-0538-2024

    Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

    Cephalexin for Oral Suspension, USP, 250mg/ 5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prep — Bryant Ranch Prepack, Inc.

  4. May 10, 2024 · Class III · Ongoing · D-0540-2024

    Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 10g'

    Cephalexin for Oral Suspension, USP, 250mg/5mL, Rx only, 200mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch Prepa — Bryant Ranch Prepack, Inc.

  5. May 10, 2024 · Class III · Ongoing · D-0536-2024

    Labeling: Not Elsewhere Classified: Front label states 100 Tablets instead of 100 ml and on the back label 'Each Tablet contains' instead of 'Each Bottle contains' No total dose per bottle listed should be 2.5 g'

    Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 100 Tablets, Relabeled by: Bryant Ranch Prepack, Inc, Burbank, CA 91504, NDC 63629-9204-1. — Bryant Ranch Prepack, Inc.

  6. May 10, 2024 · Class III · Ongoing · D-0537-2024

    Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g

    Cephalexin for Oral Suspension, USP, 125mg per 5mL, Rx only, 200mL (when mixed), Each contains: cephalexin monohydrate, USP equivalent to 2.5g of cephalexin in a strawberry flavored mixture. Manufactured by Alkem Laborat — Bryant Ranch Prepack, Inc.

  7. May 10, 2024 · Class III · Ongoing · D-0539-2024

    Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle contains: cephalexin monohydrate, USP equivalent to 5g'

    Cephalexin for Oral Suspension, USP, 250mg per 5mL, Rx only, 100mL (when mixed), Each contains cephalexin monohydrate, USP equivalent to 5g cephalexin. Manufactured by Alkem Laboratories Ltd, Relabeled by: Bryant Ranch P — Bryant Ranch Prepack, Inc.

  8. April 12, 2021 · Class II · Ongoing · D-0342-2021

    Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found during related substance test analysis of Cephalexin

    Cephalexin for Oral Suspension, Generic for Keflex, USP, Powder for Oral Suspension, 250 mg/5mL, Pkg Size 100, Rx only, Repackaged by Preferred Pharmaceuticals, Inc., Mfg: Ascend Laboratories, LLC, NDC #: 68788-7529-1, — Preferred Pharmaceuticals, Inc.

  9. January 22, 2021 · Class II · Terminated · D-0264-2021

    CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

    Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545 — Ascend Laboratories LLC

  10. January 22, 2021 · Class II · Terminated · D-0263-2021

    CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.

    Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-54 — Ascend Laboratories LLC

  11. December 17, 2020 · Class II · Terminated · D-0179-2021

    Failed Impurity/Degradation Specifications

    Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany — Ascend Laboratories LLC

  12. December 17, 2020 · Class II · Terminated · D-0178-2021

    Failed Impurity/Degradation Specifications

    Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany — Ascend Laboratories LLC

  13. November 23, 2020 · Class II · Terminated · D-0185-2021

    Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.

    Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai — Ascend Laboratories LLC

  14. August 24, 2020 · Class II · Terminated · D-1566-2020

    Sub-Potent Drug: Out of specification test results for potency (below specification).

    Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when mixed, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-4177-73. — Teva Pharmaceuticals USA

  15. August 24, 2020 · Class II · Terminated · D-0012-2021

    CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

    Cephalexin for Oral Suspension, USP 125 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4175-73, b) 200 mL bottle when mixed, NDC 0093-4175-74, Teva Pharmaceuticals USA, — Teva Pharmaceuticals USA

  16. August 24, 2020 · Class II · Terminated · D-0013-2021

    CGMP deviations; there is a possibility that some bottles in these lots may have the active ingredient above and/or below specification limits.

    Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, a) 100 mL bottle when mixed, NDC 0093-4177-73, b) 200 mL bottle when mixed, NDC 0093-4177-74, Teva Pharmaceuticals USA, — Teva Pharmaceuticals USA

  17. January 9, 2019 · Class II · Terminated · D-0423-2019

    CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.

    Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01 — Lupin Pharmaceuticals Inc.

What do the recall classes mean?

Class I: The most serious type: there is a reasonable chance that using the product will cause serious health problems or death.
Class II: Using the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
Class III: Using the product is not likely to cause health problems (for example a labeling or packaging issue).

Official identifiers

RxCUI (RxNorm)197454, 309110, 309112, 309113, 309114, 309115, 637173, 645617
SPL set ID of the quoted labele54df878-c235-4aa3-af33-fe5287c73138
FDA labels (SPL)139
FDA applications14 ANDA
Active ingredients (FDA)CEPHALEXIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Cephalexin, PD-Rx Pharmaceuticals, Inc., effective September 14, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
  2. NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  3. Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
  4. Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
  5. Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026

openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →

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