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Prescription medicine · generic available

Amoxicillin

Brand names: Amoxil

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
8Recalls (FDA reports)
32Companies
1976First FDA approval on file

Quick answers

What is Amoxicillin used for?
The FDA-approved label (Amoxicillin, USAntibiotics, LLC, July 7, 2026) says: “1. INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and ​ ​ β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. Infections of the Genitourinary Tract …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Amoxicillin have a boxed warning?
No. None of the 212 FDA labels we found for this medicine has a boxed warning.
Is there a shortage of Amoxicillin?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Amoxicillin been recalled?
FDA enforcement reports list 8 recalls of products of this medicine; the newest started April 13, 2022 (Class II). A recall usually concerns specific lots, not every product.
Who makes Amoxicillin?
32 companies list prescription products of Amoxicillin in the FDA NDC Directory, including A-S Medication Solutions, NuCare Pharmaceuticals, Inc. and Proficient Rx LP.

What Amoxicillin is used for

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

1. INDICATIONS AND USAGE Adults and Pediatric Patients Upper Respiratory Tract Infections of the Ear, Nose, and Throat: Amoxicillin is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of Streptococcus species. (α-and ​ ​ β-hemolytic isolates only), Streptococcus pneumoniae, Staphylococcus spp., or Haemophilus influenzae. Infections of the Genitourinary Tract …

— FDA label: Amoxicillin, USAntibiotics, LLC, effective July 7, 2026. Read the full label on DailyMed →

The FDA has 212 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 212 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Powder, for suspension · Tablet, film coated · Tablet, chewable · Tablet, coated · For suspension
RouteOral
Prescription products277 in the FDA NDC Directory
Brand namesAmoxil

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 Amoxicillin, by strength and form
Strength and formGeneric or brandPharmacies pay
amoxicillin 125 mg
tablet, chewable		 Generic $0.2091 per tablet
amoxicillin 125 mg/5 mL
powder, for suspension		 Generic $0.0175–$0.0225 per mL
9 packages, lowest to highest
amoxicillin 200 mg/5 mL
powder, for suspension		 Generic $0.0367–$0.0409 per mL
12 packages, lowest to highest
amoxicillin 250 mg
capsule		 Generic $0.0682 per capsule
amoxicillin 250 mg
tablet, chewable		 Generic $0.2997 per tablet
amoxicillin 250 mg/5 mL
powder, for suspension		 Generic $0.0245–$0.0305 per mL
12 packages, lowest to highest
amoxicillin 400 mg/5 mL
for suspension		 Generic $0.0336–$0.0457 per mL
3 packages, lowest to highest
amoxicillin 400 mg/5 mL
powder, for suspension		 Generic $0.0336–$0.0457 per mL
15 packages, lowest to highest
amoxicillin 500 mg
capsule		 Generic $0.0793 per capsule
amoxicillin 500 mg
tablet, film coated		 Generic $0.0894 per tablet
amoxicillin 875 mg
tablet, coated		 Generic $0.1544 per tablet
amoxicillin 875 mg
tablet, film coated		 Generic $0.1544 per tablet

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

  • NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
  • ANDA: Abbreviated New Drug Application: how a generic version is approved.
Brand and biologic applications
ApplicationSponsorApprovedLater changes approved
NDA050760
AMOXIL		 Us AntibioticsApril 15, 1999 20, latest May 1, 2024
2024: Labeling · 2022: Labeling · 2015: Labeling

Generic approvals (22)

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. April 13, 2022 · Class II · Terminated · D-1025-2022

    cGMP deviations: Temperature abuse

    Amoxicillin Capsules, USP, 500 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0781-2613-01 — Mckesson Medical-Surgical Inc. Corporate Office

  2. January 26, 2022 · Class II · Terminated · D-0165-2024

    CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. — CARDINAL HEALTHCARE

  3. January 26, 2022 · Class II · Terminated · D-0166-2024

    CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20 — CARDINAL HEALTHCARE

  4. November 4, 2016 · Class III · Terminated · D-0147-2017

    Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.

    Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01 — West-Ward Pharmaceuticals Corp.

  5. June 24, 2016 · Class II · Terminated · D-1470-2016

    Superpotent drug: Out of specification test result for assay during stability testing.

    Amoxicillin for Oral Suspension USP, 400 mg/ 5 mL, 50 mL bottle, Rx only, Manufactured In Canada by: Teva Canada Limited, Toronto, Canada, NDC 0093-4161-76 — Teva North America

  6. June 18, 2013 · Class III · Terminated · D-803-2013

    Discoloration: This recall is being carried out due to an orange to brown discolored Amoxicillin powder on the inner foil seal of the bottles. This is an expansion of RES 65050.

    Amoxicillin for Oral Suspension, USP 200 mg/5 mL, a) 75 mL bottle NDC 0093-4160-78 and b) 100 mL bottle NDC 0093-4160-73, Rx Only, Manufactured in Canada by: Teva Canada Limited, Toronto, Canada M1B2K9, Manufactured for: — Teva Pharmaceuticals USA, Inc.

  7. April 26, 2013 · Class III · Terminated · D-598-2013

    Discoloration: This recall is being carried out due to a yellow to brown discolored Amoxicillin powder on the inner foil seal of the bottles.

    Amoxicillin for Oral Suspension, USP 400mg/5mL, NDC 0093-4161-78 (75ml) and 0093-4161-73 (100mL) — Teva Pharmaceuticals USA, Inc.

  8. April 18, 2013 · Class II · Terminated · D-268-2013

    Presence of Foreign Substance, Sandoz is recalling certain lots of Amoxicillin Capsules, USP 500 mg due to potential contamination with fragments of stainless steel wire mesh.

    Amoxicillin Capsules USP 500 mg, Manufactured in Austria by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540, Rx only. Manufactured in 500 ct (NDC 0781-2613-05) and 30 ct (NDC 0781-2613-31) bottles. — Sandoz Incorporated

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)239191, 308177, 308182, 308189, 308191, 308192, 308194, 313797, 313850, 598025 … (+1)
SPL set ID of the quoted label06e5c07d-d95c-4955-8d35-a4703ca2359e
FDA labels (SPL)212
FDA applicationsNDA050760, 22 ANDA
Active ingredients (FDA)AMOXICILLIN

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Amoxicillin, USAntibiotics, LLC, effective July 7, 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 →

Report an error → · Information for medicine makers