Quick answers
- What is Isotretinoin used for?
- The FDA-approved label (Absorica LD, Sun Pharmaceutical Industries, Inc., August 19, 2026) says: “ABSORICA 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. …” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Isotretinoin have a boxed warning?
- Yes. The FDA label for Absorica LD has a boxed warning, the FDA’s strongest warning. Read it on the full label and ask your pharmacist.
- Is there a shortage of Isotretinoin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Isotretinoin been recalled?
- FDA enforcement reports list 16 recalls of products of this medicine; the newest started April 6, 2026 (Class II). A recall usually concerns specific lots, not every product.
- Who makes Isotretinoin?
- 14 companies list prescription products of Isotretinoin in the FDA NDC Directory, including Sun Pharmaceutical Industries, Inc., Zydus Pharmaceuticals USA Inc. and Zydus Lifesciences Limited.
What Isotretinoin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
ABSORICA 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. …
— FDA label: Absorica LD, Sun Pharmaceutical Industries, Inc., effective August 19, 2026. Read the full label on DailyMed →
The FDA has 19 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.
This label has a boxed warning. Read it on the full label →
17 of 19 FDA labels for this medicine have a boxed warning.
Forms and how it is given
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.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| isotretinoin 10 mg capsule | Generic | $1.96–$4.21 per capsule 6 packages, lowest to highest |
| isotretinoin 10 mg capsule, gelatin coated | Generic | $1.96 per capsule |
| isotretinoin 10 mg capsule, liquid filled | Generic | $1.96–$4.21 per capsule 7 packages, lowest to highest |
| isotretinoin 16 mg capsule | Brand: Absorica LD | $38.41 per capsule |
| isotretinoin 20 mg capsule | Generic | $1.93–$4.18 per capsule 6 packages, lowest to highest |
| isotretinoin 20 mg capsule | Brand: Absorica | $35.74 per capsule |
| isotretinoin 20 mg capsule, gelatin coated | Generic | $1.93 per capsule |
| isotretinoin 20 mg capsule, liquid filled | Generic | $1.93–$4.18 per capsule 7 packages, lowest to highest |
| isotretinoin 24 mg capsule | Brand: Absorica LD | $42.23 per capsule |
| isotretinoin 25 mg capsule | Generic | $10.59 per capsule |
| isotretinoin 30 mg capsule | Generic | $2.01–$5.43 per capsule 6 packages, lowest to highest |
| isotretinoin 30 mg capsule | Brand: Absorica | $38.24 per capsule |
| isotretinoin 30 mg capsule, gelatin coated | Generic | $2.01 per capsule |
| isotretinoin 30 mg capsule, liquid filled | Generic | $2.01–$5.43 per capsule 6 packages, lowest to highest |
| isotretinoin 32 mg capsule | Brand: Absorica LD | $42.42 per capsule |
| isotretinoin 40 mg capsule | Generic | $2.19–$5.83 per capsule 6 packages, lowest to highest |
| isotretinoin 40 mg capsule | Brand: Absorica | $38.22 per capsule |
| isotretinoin 40 mg capsule, gelatin coated | Generic | $2.19 per capsule |
| isotretinoin 40 mg capsule, liquid filled | Generic | $2.19–$5.83 per capsule 7 packages, lowest to highest |
NADAC list of November 4, 2026; these prices took effect between December 17, 2025 and 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.
- Sun Pharmaceutical Industries, Inc.16 products
- Zydus Pharmaceuticals USA Inc.10 products
- Zydus Lifesciences Limited10 products
- Aurobindo Pharma Limited9 products
- Upsher-Smith Laboratories, LLC8 products
- Mayne Pharma8 products
- Amneal Pharmaceuticals NY LLC6 products
- Actavis Pharma, Inc.6 products
- JG Pharma Inc.4 products
- BluePoint Laboratories4 products
- Teva Pharmaceuticals USA, Inc.4 products
- Dr. Reddy's Laboratories Limited4 products
- Mylan Pharmaceuticals Inc.4 products
- Amneal Pharmaceuticals LLC4 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.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA021951 ABSORICA | Sun Pharm Inds Inc | May 25, 2012 | 24, latest October 7, 2026 2026: REMS · 2026: Labeling · 2026: Labeling |
| NDA211913 ABSORICA LD | Sun Pharm | November 5, 2019 | 10, latest October 7, 2026 2026: REMS · 2026: Labeling · 2026: Labeling |
Generic approvals (14)
- ANDA075945Mylan Pharms Inc · November 8, 2002
- ANDA076135Teva Pharms USA · April 11, 2003
- ANDA076356Teva Pharms USA · April 11, 2003
- ANDA076485Upsher Smith Labs · January 19, 2012
- ANDA202099DR Reddys Labs Ltd · March 25, 2013
- ANDA207792Amneal Pharms Ny · September 29, 2017
- ANDA205063Actavis Labs Fl · March 31, 2021
- ANDA213571Upsher Smith Labs · April 12, 2021
- ANDA212333Upsher Smith Labs · September 21, 2021
- ANDA211568Zydus Pharms · August 29, 2023
- ANDA218194Aurobindo Pharma · January 29, 2024
- ANDA216633Zydus Pharms · May 22, 2025
- ANDA216097Amneal Pharms Ny · October 7, 2025
- ANDA220336Aurobindo Pharma Ltd · September 10, 2026
Shortage status
The FDA drug shortage list does not show these products.
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.
-
April 6, 2026 · Class II · Ongoing · D-0521-2026
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister packs NDC 0555-1054-60; b) 30-count carton, NDC 0555-1054-86, with 3X10 blister pack NDC 0555-1054-60; Rx — Teva Pharmaceuticals USA, Inc
-
February 24, 2026 · Class II · Ongoing · D-0399-2026
Failed Dissolution Specifications
Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93. — MYLAN PHARMACEUTICALS INC
-
January 12, 2026 · Class II · Ongoing · D-0446-2026
Superpotent and Subpotent
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack). — Teva Pharmaceuticals USA, Inc
-
January 12, 2026 · Class II · Ongoing · D-0445-2026
Superpotent and Subpotent
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack). — Teva Pharmaceuticals USA, Inc
-
March 28, 2024 · Class II · Ongoing · D-0439-2024
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15 — Teva Pharmaceuticals USA, Inc
-
October 16, 2019 · Class III · Terminated · D-0321-2020
Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1174-3 — Amneal Pharmaceuticals, Inc.
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December 7, 2018 · Class III · Terminated · D-1207-2019
Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring.
Absorica (Isotretinoin) Capsules 30 mg USP, 30 capsules (3x10 Prescription Packs) Rx only, Manufactured by: Galephar Pharmaceutical Research Inc. Humacao, PR 00792, Distributed by: Sun Pharmaceutical Industries Inc. Cran — Sun Pharmaceutical Industries, Inc.
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May 22, 2017 · Class II · Terminated · D-0883-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
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May 22, 2017 · Class II · Terminated · D-0885-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 30 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
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May 22, 2017 · Class II · Terminated · D-0884-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 20 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
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May 22, 2017 · Class II · Terminated · D-0886-2017
Failed Dissolution Specifications: out of specification results observed for low dissolution.
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bac — Dr. Reddy's Laboratories, Inc.
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February 15, 2017 · Class III · Terminated · D-0507-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupa — Dr. Reddy's Laboratories, Inc.
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February 15, 2017 · Class III · Terminated · D-0509-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupa — Dr. Reddy's Laboratories, Inc.
-
February 15, 2017 · Class III · Terminated · D-0506-2017
Failed dissolution specifications - low dissolution results at S3 stage.
Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By: Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachup — Dr. Reddy's Laboratories, Inc.
-
August 29, 2016 · Class III · Terminated · D-0098-2017
Failed Dissolution Specifications
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 5 — Dr. Reddy's Laboratories, Inc.
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June 26, 2015 · Class II · Terminated · D-1288-2015
Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell.
Absorica (isotretinoin) Capsules, 25 mg, Packaged in 3 x 10 Count Blister Cards/Box, Rx Only. Manufactured for: RANBAXY LABORATORIES, INC Jacksonville, FL 32257 USA. NDC: 10631-133-31. — Ranbaxy 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
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Absorica LD, Sun Pharmaceutical Industries, Inc., effective August 19, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- 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 →