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Prescription medicine · generic available

Fluoxetine

Brand names: Prozac

Also listed by the FDA as: fluoxetine hydrochloride · fluoxetine

Drug class: Serotonin Reuptake Inhibitor

The FDA’s “Established Pharmacologic Class”: the group of medicines that work in a similar way.

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

YesBoxed warning
None listedFDA shortage list
7Recalls (FDA reports)
54Companies
1987First FDA approval on file

Quick answers

What is Fluoxetine used for?
The FDA-approved label (Prozac, Dista Products Company, January 8, 2026) says: “PROZAC ® is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder […]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) […]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa […]. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Does Fluoxetine have a boxed warning?
Yes. The FDA label for Prozac has a boxed warning (“WARNING: SUICIDAL THOUGHTS AND BEHAVIORS”), the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
Is there a shortage of Fluoxetine?
No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
Has Fluoxetine been recalled?
FDA enforcement reports list 7 recalls of products of this medicine; the newest started May 27, 2025 (Class II). A recall usually concerns specific lots, not every product.
Who makes Fluoxetine?
54 companies list prescription products of Fluoxetine in the FDA NDC Directory, including Bryant Ranch Prepack, A-S Medication Solutions and Aurobindo Pharma Limited.

What Fluoxetine is used for

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

PROZAC ® is indicated for the treatment of: Acute and maintenance treatment of Major Depressive Disorder […]. Acute and maintenance treatment of obsessions and compulsions in patients with Obsessive Compulsive Disorder (OCD) […]. Acute and maintenance treatment of binge-eating and vomiting behaviors in patients with moderate to severe Bulimia Nervosa […]. …

— FDA label: Prozac, Dista Products Company, effective January 8, 2026. Read the full label on DailyMed →

The FDA has 155 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.

Conditions named on the label

These condition names appear word for word in the label’s “Indications and Usage” text (matched with a reviewed table). Each page lists hospitals whose own websites name the condition.

Major Depressive DisorderBipolar disorderPanic DisorderOCD

Related medical specialties

Psychiatry

Boxed warning

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

This label has a boxed warning. Its heading: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS. Read it on the full label →

155 of 155 FDA labels for this medicine have a boxed warning.

Forms and how it is given

Dosage formsCapsule · Tablet, film coated · Tablet · Tablet, coated · Solution · Liquid · Capsule, delayed release pellets · For solution
RouteOral
Prescription products228 in the FDA NDC Directory
Brand namesProzac

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 Fluoxetine, by strength and form
Strength and formGeneric or brandPharmacies pay
fluoxetine 60 mg
tablet		 Generic $0.1846 per tablet
fluoxetine hydrochloride 10 mg
capsule		 Generic $0.0339 per capsule
fluoxetine hydrochloride 10 mg
tablet		 Generic $0.0646 per tablet
fluoxetine hydrochloride 10 mg
tablet, coated		 Generic $0.0646 per tablet
fluoxetine hydrochloride 10 mg
tablet, film coated		 Generic $0.0646 per tablet
fluoxetine hydrochloride 20 mg
capsule		 Generic $0.0292 per capsule
fluoxetine hydrochloride 20 mg
tablet		 Generic $0.0971 per tablet
fluoxetine hydrochloride 20 mg
tablet, coated		 Generic $0.0971 per tablet
fluoxetine hydrochloride 20 mg
tablet, film coated		 Generic $0.0971 per tablet
fluoxetine hydrochloride 20 mg/5 mL
for solution		 Generic $0.2171 per mL
fluoxetine hydrochloride 20 mg/5 mL
liquid		 Generic $0.2171 per mL
fluoxetine hydrochloride 20 mg/5 mL
solution		 Generic $0.2171 per mL
fluoxetine hydrochloride 40 mg
capsule		 Generic $0.0539 per capsule
fluoxetine hydrochloride 60 mg
tablet		 Generic $0.1846 per tablet
fluoxetine hydrochloride 60 mg
tablet, film coated		 Generic $0.1846 per tablet
fluoxetine hydrochloride 90 mg
capsule, delayed release pellets		 Generic $30.55 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

  • 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
NDA018936
PROZAC, SARAFEM		 Eli Lilly and CoDecember 29, 1987 88, latest August 18, 2023
2023: Labeling · 2021: Labeling · 2020: Labeling

Generic approvals (31)

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 27, 2025 · Class II · Completed · D-0455-2025

    CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

    Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-30 — Torrent Pharma Inc.

  2. May 27, 2025 · Class II · Completed · D-0456-2025

    CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

    Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 INDIA; Manufactured for: TORRENT PHARMA INC., Basking Ridge, NJ 07920. NDC: 13668-473-91 (Cart — Torrent Pharma Inc.

  3. April 13, 2015 · Class II · Terminated · D-0971-2015

    Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

    Fluoxetine Capsules USP, 20 mg, packaged in a) 500-count bottles (NDC 50111-648-02), and (b) 1000- count bottles (NDC 50111-648-03), Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manu — Teva Pharmaceuticals USA

  4. April 13, 2015 · Class II · Terminated · D-0970-2015

    Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

    Fluoxetine Capsules USP, 10 mg, in 100-count bottles, Rx only, Manufactured by Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland, Manufactured for Teva Pharmaceuticals USA, Sellersville, PA 18960. NDC 50111-647-01 — Teva Pharmaceuticals USA

  5. February 14, 2014 · Class II · Terminated · D-1279-2014

    Chemical Contamination: The recalling firm received notice that their supplier is recalling capsules due to complaints of capsules having an unusual odor.

    Fluoxetine Capsules, USP, 20 mg, 30-count bottles, Rx only, Distributed by: Wal-Mart, Bentonville, AR 72716; Manufactured by: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960; Packaged by: Legacy Pharmaceutical Packaging — Legacy Pharmaceutical Packaging

  6. February 12, 2014 · Class II · Terminated · D-1280-2014

    Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

    Fluoxetine Capsules USP, 20 mg, packaged in a) 100-count bottles (NDC 50111-648-01), b) 500-count bottles (NDC 50111-648-02), c) 1000-count bottles (NDC 50111-648-03), and d) 2000-count bottles (NDC 50111-648-44), Rx onl — Teva Pharmaceuticals USA

  7. February 12, 2014 · Class II · Terminated · D-1281-2014

    Chemical Contamination: Recall due to a customer complaint trend regarding capsule odor.

    Fluoxetine Capsules USP, 10 mg, 100-count bottles, Rx only, Manufactured in Poland By: Pliva Krakow Pharmaceutical Company S.A., Krakow, Poland; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 501 — Teva Pharmaceuticals USA

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)104849, 205535, 248642, 261287, 310384, 310385, 310386, 313989, 313990, 313995 … (+1)
SPL set ID of the quoted labelc88f33ed-6dfb-4c5e-bc01-d8e36dd97299
FDA labels (SPL)155
FDA applicationsNDA018936, 31 ANDA
Active ingredients (FDA)FLUOXETINE

Sources

  1. FDA-approved label on DailyMed (National Library of Medicine) — Prozac, Dista Products Company, effective January 8, 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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