Prescription medicine
Cephalexin First approved as Keflex
Cephalexin (Keflex) is a prescription medicine with an FDA approval on record since 1971. FDA's NDC Directory lists it from 35 generic labelers, and pharmacies paid $0.120 per cephalexin 500 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the cephalexin FDA label on DailyMed (effective December 31, 2020, Teva Pharmaceuticals USA, Inc.); the NDA 50405 record on Drugs@FDA; every cephalexin label on DailyMed.
Highlights of the record
FDA label of December 31, 2020; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageCephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin
Forms and strengths
- 250 mg
- 333 mg
- 500 mg
- 750 mg
- 125 mg/5ml
- 250 mg/5ml
Capsule; for suspension; powder for suspension; tablet; film-coated tablet.
On the market
- Earliest approval on file
- January 4, 1971 Keflex, Pragma; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 44 first April 26, 1976; 15 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 35 of which 35 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.120 per capsule Cephalexin 500 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 22 since 2014 0 Class I among all firms' recalls; latest May 23, 2025
- FAERS reports
- 21,515 through July 30, 2026
What is cephalexin used for?
From the label: indications and usageCephalexin is a cephalosporin antibacterial drug indicated for the treatment of the following infections caused by susceptible isolates of designated bacteria: Respiratory tract infection ( 1.1 ) Otitis media ( 1.2 ) Skin and skin structure infections ( 1.3 ) Bone infections ( 1.4 ) Genitourinary tract infections ( 1.5 ) To reduce the development of drug-resistant bacteria and maintain the effectiveness of cephalexin capsules, and cephalexin for oral suspension and other antibacterial drugs, cephalexin capsules, and cephalexin for oral suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. […]
Conditions named in the indications of cephalexin's FDA labels, with every medicine labeled for each:
From other cephalexin labelsBacterial infections: Cephalexin is indicated for the treatment of respiratory tract infections caused by susceptible isolates of Streptococcus pneumoniae and Streptococcus pyogenes.
Urinary tract infections: Cephalexin is indicated for the treatment of genitourinary tract infections, including acute prostatitis, caused by susceptible isolates of Escherichia coli, Proteus mirabilis, and Klebsiella pneumoniae.
FDA pharmacologic class: Cephalosporin Antibacterial.
Source: FDA drug label (Cephalexin), Teva Pharmaceuticals USA, Inc., effective December 31, 2020 (SPL set 19307ff0-71de-477b-965d-ea243e5ede3a), via openFDA; the full label on DailyMed
Is there a generic for cephalexin (Keflex)?
The FDA approved the first generic cephalexin on April 26, 1976. 44 generic applications are approved; 15 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists cephalexin from 35 labelers under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1971 earliest approval on file
- 1976 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for cephalexin (Keflex)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.120 per Cephalexin 500 mg capsule, down 6% from $0.127 on October 8, 2025. Prices per unit in the table differ many-fold by strength, form and brand, so compare like with like. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Cephalexin 500 mg capsule (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Cephalexin 125 mg/5 mL suspension | Generic | $0.0597 per mL | n/a | -14% |
| Cephalexin 250 mg capsule | Generic | $0.0905 per capsule | $2.71 | -6% |
| Cephalexin 250 mg tablet | Generic | $0.743 per tablet | $22.29 | -20% |
| Cephalexin 250 mg/5 mL suspension | Generic | $0.0603 per mL | n/a | -11% |
| Cephalexin 500 mg capsule | Generic | $0.120 per capsule | $3.60 | -6% |
| Cephalexin 500 mg tablet | Generic | $1.27 per tablet | $37.96 | -21% |
| Cephalexin 750 mg capsule | Generic | $5.11 per capsule many times the lowest per-tablet cost; NADAC records the price, not why | $153.35 | -19% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has cephalexin been recalled?
The FDA's Enforcement Report lists 22 recalls naming cephalexin since 2014: 0 Class I (the most serious), 16 Class II, 6 Class III; 8 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 23, 2025 | Class II | Ascend Laboratories, LLC | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability … |
| May 10, 2024 | Class III | Bryant Ranch Prepack, Inc. | 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 … |
| May 10, 2024 | Class III | Bryant Ranch Prepack, Inc. | Labeling: Not Elsewhere Classified: Back label states Each contains: cephalexin monohydrate, USP equivalent to 2.5g' instead of Each Bottle contains … |
| May 10, 2024 | Class III | Bryant Ranch Prepack, Inc. | Labeling: Not Elsewhere Classified: Back Label states 'Each contains: cephalexin monohydrate, USP equivalent to 5g' instead of Each Bottle contains: cephalexin … |
| May 10, 2024 | Class III | Bryant Ranch Prepack, Inc. | Labeling: Not Elsewhere Classified: Back Label states Each contains: cephalexin monohydrate, USP equivalent to 5g' on the back label instead of Each Bottle … |
| April 12, 2021 | Class II | Preferred Pharmaceuticals, Inc. | Failed Impurities/degradation specifications: Repackager recall due to Out of Specification detected by manufacturer for Individual Unidentified Impurity found … |
| January 22, 2021 | Class II | Ascend Laboratories LLC | CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit. |
| December 17, 2020 | Class II | Ascend Laboratories LLC | Failed Impurity/Degradation Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the cephalexin label say about other medicines?
The cephalexin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name cephalexin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Metformin | drug interactions | DRUG INTERACTIONS Metformin: increased metformin concentrations. |
| Probenecid | drug interactions | Monitor for hypoglycemia. ( 7.1 ) Probenecid - The renal excretion of cephalexin is inhibited by probenecid. |
Source: FDA drug label (Cephalexin), Teva Pharmaceuticals USA, Inc., effective December 31, 2020 (SPL set 19307ff0-71de-477b-965d-ea243e5ede3a), via openFDA; the full label on DailyMed
What do FAERS reports show for cephalexin?
The FDA Adverse Event Reporting System holds 21,515 reports that list cephalexin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,795 are coded as a death and 7,498 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as cephalexin?
26 other medicines are given the same way (oral) and in the same FDA class as cephalexin or labeled mainly for the same use (bacterial infections), the same class first. Bacterial infections lists all 51 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cefdinir | Bacterial infections | 26 labelers | $0.458 per capsule 300 mg capsule | No current entry |
| Cefuroxime | Bacterial infections, Urinary tract infections | 17 labelers | $0.280 per tablet 250 mg tablet | No current entry |
| Cefadroxil | Bacterial infections, Urinary tract infections | 19 labelers | $0.269 per capsule 500 mg capsule | No current entry |
| Cefpodoxime | Bacterial infections | 11 labelers | $1.04 per tablet 100 mg tablet | No current entry |
| Cefprozil | Bacterial infections | 7 labelers | $0.925 per tablet 500 mg tablet | No current entry |
| Cefixime | Bacterial infections, Urinary tract infections | 6 labelers | $10.03 per capsule 400 mg capsule | No current entry |
| Doxycycline | Bacterial infections, Urinary tract infections | 71 labelers | $0.118 per tablet 100 mg tablet | A presentation being discontinued |
| Amoxicillin | Bacterial infections | 38 labelers | $0.0788 per capsule 500 mg capsule | No current entry |
Every medicine labeled for the same conditions as cephalexin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does cephalexin compare with medicines for the same use?
18 side-by-side pages set cephalexin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to cephalexin
- 26 medicines for the same use
- Other cephalosporins
- the pharmacologic class, with prices and generics
- Cephalexin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other