Prescription medicine
Isotretinoin Brand names: Absorica, Zenatane, Accutane, Amnesteem, Claravis
Isotretinoin (Accutane) is a prescription medicine with an FDA approval on record since 1982. FDA's NDC Directory lists it from 13 generic labelers, and pharmacies paid $11.94 per isotretinoin 10 mg capsule in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the isotretinoin FDA label on DailyMed (effective August 19, 2026, Sun Pharmaceutical Industries, Inc.); the NDA 18662 record on Drugs@FDA; every isotretinoin label on DailyMed.
Highlights of the record
FDA label of August 19, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY ABSORICA/ABSORICA.
LD can cause life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of ABSORICA/ABSORICA LD even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected. If pregnancy occurs, discontinue ABSORICA/ABSORICA LD immediately and refer the patient to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications (4), Warnings and Precautions (5.1), and Use in Specific Populations (8.1) ]. Because of the risk of embryo-fetal toxicity, ABSORICA and ABSORICA LD are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions (5.2) ]. WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY See full prescribing information for complete boxed warning. ABSORICA/ABSORICA LD can cause life-threatening birth defects and is contraindicated in pregnancy. […]
Used for
From the label: indications and usageABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater.
Forms and strengths
- 8 mg
- 10 mg
- 16 mg
- 20 mg
- 24 mg
- 25 mg
- 30 mg
- 32 mg
- 35 mg
- 40 mg
Capsule; liquid-filled capsule; gelatin-coated capsule.
On the market
- Earliest approval on file
- May 7, 1982 Accutane, Hoffmann La Roche; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first November 8, 2002; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 14 of which 13 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- August 4, 2035 Absorica Ld capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $11.94 per capsule Isotretinoin 10 mg capsule
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 16 since 2015 0 Class I among all firms' recalls; latest April 6, 2026
- FAERS reports
- 49,172 through July 30, 2026
What is isotretinoin used for?
From the label: indications and usageABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. Because of significant adverse reactions associated with its use, ABSORICA and ABSORICA LD are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. […]
Conditions named in the indications of isotretinoin's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Retinoid.
Source: FDA drug label (Absorica LD), Sun Pharmaceutical Industries, Inc., effective August 19, 2026 (SPL set 3ef0cff8-19c1-4441-b780-fca6c7ee1615), via openFDA; the full label on DailyMed
What does the patient leaflet for isotretinoin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about ABSORICA and ABSORICA LD?ABSORICA and ABSORICA LD can cause serious side effects, including: ABSORICA and ABSORICA LD can harm your unborn baby, including birth defects (deformed babies), loss of a baby before birth (miscarriage), death of the baby, and early (premature) births. Patients who are pregnant or who plan to become pregnant must not take ABSORICA or ABSORICA LD. Because of the risk of birth defects, ABSORICA and ABSORICA LD are only available through a special program called the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider must be enrolled in the iPLEDGE REMS for you to be prescribed ABSORICA or ABSORICA LD. Before you start treatment with ABSORICA or ABSORICA LD, you must enroll in the iPLEDGE REMS. You must understand and agree to do everything required in the iPLEDGE REMS. […] Stop taking ABSORICA or ABSORICA LD and tell your healthcare provider right away if you or a family member notices that you get any of the following signs and symptoms of depression or psychosis: start to feel sad or have crying spells lose interest in activities you once enjoyed sleep too much or have trouble sleeping become more irritable, angry, or aggressive than usual (for example, temper outbursts, thoughts of violence have trouble concentrating withdraw from your friends or family feel like you have no energy have feelings of worthlessness or guilt start having thoughts about hurting yourself or taking your own life (suicidal thoughts) Your healthcare provider may tell you to see a mental healthcare professional if you get any of these symptoms. […]
From the patient leaflet: What should I avoid while taking ABSORICA or ABSORICA LD?Do not give blood during treatment with ABSORICA or ABSORICA LD and for 1 month after stopping ABSORICA or ABSORICA LD. If someone who is pregnant gets your donated blood, ABSORICA/ABSORICA LD may cause miscarriage, premature birth, birth defects or death of the baby. Do not take other medicines or herbal products during treatment with ABSORICA or ABSORICA LD unless you talk to your healthcare provider. See “Before taking ABSORICA or ABSORICA LD” Do not drive at night until you know if ABSORICA or ABSORICA LD affect your vision. ABSORICA and ABSORICA LD may decrease your ability to see in the dark. Do not have cosmetic procedures to smooth your skin, including waxing, dermabrasion, or laser procedures, during treatment with ABSORICA or ABSORICA LD and for at least 6 months after you stop. ABSORICA and ABSORICA LD can increase your chance of scarring from these procedures. […]
From the patient leaflet: How should I store ABSORICA and ABSORICA LD?Store ABSORICA and ABSORICA LD at room temperature, 68°F to 77°F (20°C to 25°C). Protect from light. Keep ABSORICA and ABSORICA LD and all medicines out of the reach of children.
Source: FDA drug label (Absorica LD), Sun Pharmaceutical Industries, Inc., effective August 19, 2026 (SPL set 3ef0cff8-19c1-4441-b780-fca6c7ee1615), via openFDA; the full label on DailyMed
Is there a generic for isotretinoin (Accutane)?
The FDA approved the first generic isotretinoin on November 8, 2002. 16 generic applications are approved; 13 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 isotretinoin from 13 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Accutane capsules; a patent listed only for Absorica Ld capsules runs to August 4, 2035. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1982 earliest approval on file
- 2002 first generic approved
- 2035 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for isotretinoin (Accutane)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $11.94 per Isotretinoin 10 mg capsule, up 6% from $11.31 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.
- Isotretinoin 20 mg capsule (generic)
- Absorica 20 mg capsule (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Amnesteem 10 mg capsule | Generic | $1.96 per capsule | $58.89 | -10% |
| Amnesteem 20 mg capsule | Generic | $1.93 per capsule | $57.97 | -10% |
| Amnesteem 30 mg capsule | Generic | $2.13 per capsule | $63.76 | -6% |
| Amnesteem 40 mg capsule | Generic | $2.21 per capsule | $66.23 | -10% |
| Claravis 10 mg capsule | Generic | $1.96 per capsule | $58.89 | -10% |
| Claravis 20 mg capsule | Generic | $1.93 per capsule | $57.97 | -10% |
| Claravis 30 mg capsule | Generic | $2.13 per capsule | $63.76 | -6% |
| Claravis 40 mg capsule | Generic | $2.21 per capsule | $66.23 | -10% |
| Isotretinoin 10 mg capsule | Generic | $11.94 per capsule | $358.08 | +6% |
| Isotretinoin 20 mg capsule | Generic | $4.25 per capsule | $127.62 | -55% |
| Isotretinoin 25 mg capsule | Generic | $10.55 per capsule | $316.54 | -4% |
| Isotretinoin 30 mg capsule | Generic | $4.47 per capsule | $134.17 | -58% |
| Isotretinoin 40 mg capsule | Generic | $6.67 per capsule | $199.96 | -52% |
| Zenatane 10 mg capsule | Generic | $1.96 per capsule | $58.89 | -10% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has isotretinoin been recalled?
The FDA's Enforcement Report lists 16 recalls naming isotretinoin since 2015: 0 Class I (the most serious), 10 Class II, 6 Class III; 5 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| April 6, 2026 | Class II | Teva Pharmaceuticals USA, Inc | Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin |
| February 24, 2026 | Class II | MYLAN PHARMACEUTICALS INC | Failed Dissolution Specifications |
| January 12, 2026 | Class II | Teva Pharmaceuticals USA, Inc | Superpotent and Subpotent |
| March 28, 2024 | Class II | Teva Pharmaceuticals USA, Inc | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit |
| October 16, 2019 | Class III | Amneal Pharmaceuticals, Inc. | Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. |
| December 7, 2018 | Class III | Sun Pharmaceutical Industries, Inc. | Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. |
| May 22, 2017 | Class II | Dr. Reddy's Laboratories, Inc. | Failed Dissolution Specifications: out of specification results observed for low dissolution. |
| February 15, 2017 | Class III | Dr. Reddy's Laboratories, Inc. | Failed dissolution specifications - low dissolution results at S3 stage. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the isotretinoin label say about other medicines?
The isotretinoin label names 5 other medicines in its interaction, contraindication or warning sections. The labels of 7 other medicines name isotretinoin. 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 |
|---|---|---|
| Aspirin | warnings and precautions | Although the overall incidence of tartrazine sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity. |
| Norethindrone | drug interactions | Capsules did not result in clinically significant changes in the pharmacokinetics of norethindrone and ethinyl estradiol when used concomitantly with a norethindrone and ethinyl estradiol oral contraceptive [see Clinical Pharmacology ( 12.3 )]. |
| Phenytoin | drug interactions | Phenytoin is known to cause osteomalacia. |
| Progesterone | drug interactions | … relevant changes in the pharmacokinetics of ethinyl estradiol and norethindrone and in the serum levels of progesterone, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). |
| Vitamin a | contraindications | ABSORICA/ABSORICA LD is contraindicated in: Pregnancy ( 8.1 ) Patients with hypersensitivity to isotretinoin (or Vitamin A) or any of its components |
Other labels that name isotretinoin
Source: FDA drug label (Absorica LD), Sun Pharmaceutical Industries, Inc., effective August 19, 2026 (SPL set 3ef0cff8-19c1-4441-b780-fca6c7ee1615), via openFDA; the full label on DailyMed
What do FAERS reports show for isotretinoin?
The FDA Adverse Event Reporting System holds 49,172 reports that list isotretinoin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 885 are coded as a death and 4,349 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 isotretinoin?
3 other medicines are given the same way (oral) and in the same FDA class as isotretinoin or labeled mainly for the same use (acne), the same class first. Acne lists all 26 medicines labeled for it, by any route. 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 |
|---|---|---|---|---|
| Tretinoin | Acne | 5 labelers | $8.53 per capsule 10 mg capsule | No current entry |
| Sulfur | Acne | none listed | n/a | No current entry |
| Salicylic acid | Acne | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as isotretinoin
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does isotretinoin compare with medicines for the same use?
2 side-by-side pages set isotretinoin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to isotretinoin
- 3 medicines for the same use
- Other retinoids
- the pharmacologic class, with prices and generics
- Isotretinoin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other