Quick answers
- What is Tretinoin used for?
- The FDA-approved label (Retin-A, Bausch Health US, LLC, May 17, 2024) says: “RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Tretinoin have a boxed warning?
- The label we quote has no boxed warning, but 5 of 56 FDA labels for this medicine do. Check the label of your own product.
- Is there a shortage of Tretinoin?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Tretinoin been recalled?
- FDA enforcement reports list 3 recalls of products of this medicine; the newest started September 25, 2026 (Class III). A recall usually concerns specific lots, not every product.
- Who makes Tretinoin?
- 26 companies list prescription products of Tretinoin in the FDA NDC Directory, including Bausch Health US, LLC, Encube Ethicals, Inc. and Bryant Ranch Prepack.
What Tretinoin is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
RETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
— FDA label: Retin-A, Bausch Health US, LLC, effective May 17, 2024. Read the full label on DailyMed →
The FDA has 56 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.
5 of 56 FDA labels for this medicine have a boxed warning.
Forms and how it is given
| Dosage forms | Cream · Gel · Capsule · Lotion |
|---|---|
| Route | Topical · Oral |
| Prescription products | 85 in the FDA NDC Directory |
| Brand names | Retin-A, Retin-A Micro, Altreno, Atralin, Renova, Tretinoin (Microsphere) |
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 |
|---|---|---|
| tretinoin 0.01% gel | Generic | $2.15–$2.42 per gram 8 packages, lowest to highest |
| tretinoin 0.025% cream | Generic | $0.4633–$0.5528 per gram 14 packages, lowest to highest |
| tretinoin 0.025% gel | Generic | $2.20–$3.02 per gram 8 packages, lowest to highest |
| tretinoin 0.05% cream | Generic | $1.18–$1.63 per gram 10 packages, lowest to highest |
| tretinoin 0.05% gel | Generic | $4.01 per gram |
| tretinoin 0.08% gel | Generic | $11.37 per gram |
| tretinoin 0.1% cream | Generic | $0.7966–$0.9474 per gram 14 packages, lowest to highest |
| tretinoin 10 mg capsule | Generic | $8.53 per capsule |
NADAC list of November 4, 2026; these prices took effect between September 23, 2026 and October 28, 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.
- Bausch Health US, LLC12 products
- Encube Ethicals, Inc.7 products
- Bryant Ranch Prepack6 products
- NuCare Pharmaceuticals, Inc.6 products
- Mylan Pharmaceuticals Inc.6 products
- A-S Medication Solutions6 products
- Padagis US LLC5 products
- Obagi Cosmeceuticals LLC4 products
- Oceanside Pharmaceuticals4 products
- Sun Pharmaceutical Industries, Inc.3 products
- Alembic Pharmaceuticals Inc.3 products
- NorthStar Rx LLC3 products
- Alembic Pharmaceuticals Limited3 products
- Aurobindo Pharma Limited2 products
- Viona Pharmaceuticals Inc2 products
- Zydus Lifesciences Limited2 products
- Preferred Pharmaceuticals Inc.2 products
- Major Pharmaceuticals1 product
- Actavis Pharma, Inc.1 product
- Par Health USA, LLC1 product
- Redpharm Drug1 product
- Glenmark Pharmaceuticals Inc., USA1 product
- American Health Packaging1 product
- Amneal Pharmaceuticals NY LLC1 product
- Mayne Pharma1 product
- Remedyrepack Inc.1 product
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 |
|---|---|---|---|
| NDA017340 RETIN-A | Bausch | January 26, 1973 | 29, latest May 13, 2016 2016: Manufacturing (CMC) · 2015: Manufacturing (CMC) · 2013: Manufacturing (CMC) |
| NDA017522 RETIN-A | Bausch | July 19, 1974 | 27, latest May 13, 2016 2016: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
| NDA017579 RETIN-A | Valeant Intl | April 18, 1975 | 21, latest May 14, 2013 2013: Manufacturing (CMC) · 2002: Labeling · 2002: Labeling |
| NDA017955 RETIN-A | Bausch | October 17, 1978 | 20, latest February 1, 2013 2013: Manufacturing (CMC) · 2002: Labeling · 2002: Labeling |
| NDA019049 RETIN-A | Bausch | September 16, 1988 | 14, latest May 13, 2016 2016: Manufacturing (CMC) · 2013: Manufacturing (CMC) · 2002: Manufacturing (CMC) |
| NDA020404 AVITA | Mylan Pharms Inc | January 14, 1997 | 4, latest January 22, 2002 2002: Manufacturing (CMC) · 2001: Manufacturing (CMC) · 2000: Manufacturing (CMC) |
| NDA020475 RETIN-A MICRO, RETIN-A-MICRO | Bausch | February 7, 1997 | 15, latest September 10, 2025 2025: Labeling · 2025: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA021108 RENOVA | Valeant Pharms North | August 31, 2000 | 7, latest May 25, 2016 2016: Manufacturing (CMC) · 2014: Manufacturing (CMC) · 2014: Manufacturing (CMC) |
| NDA022070 ATRALIN | Dow Pharm | July 26, 2007 | 3, latest January 5, 2015 2015: Manufacturing (CMC) · 2014: Labeling · 2008: Manufacturing (CMC) |
| NDA209353 ALTRENO | Dow Pharm | August 23, 2018 | — |
Generic approvals (25)
- ANDA075213Padagis Us · December 24, 1998
- ANDA075264Padagis Us · December 24, 1998
- ANDA075265Padagis Us · December 24, 1998
- ANDA075529Padagis Us · February 22, 2000
- ANDA075589Padagis Us · June 11, 2002
- ANDA201687Ph Health · October 24, 2012
- ANDA207955Mylan · August 13, 2015
- ANDA208279Glenmark Pharms Ltd · December 23, 2016
- ANDA211645Sun Pharma Canada · January 22, 2019
- ANDA211644Sun Pharma Canada · January 25, 2019
- ANDA215713Sun Pharma Canada · January 5, 2023
- ANDA215609Encube · August 22, 2023
- ANDA218561Zydus Lifesciences · April 25, 2024
- ANDA217804Alembic · April 29, 2024
- ANDA218246Aurobindo Pharma Ltd · January 13, 2025
- ANDA218245Aurobindo Pharma Ltd · February 27, 2025
- ANDA217587Encube · March 3, 2025
- ANDA217588Encube · March 3, 2025
- ANDA217831Encube · July 10, 2025
- ANDA218399Alembic · August 14, 2025
- ANDA217833Encube · February 10, 2026
- ANDA217832Encube · March 25, 2026
- ANDA217497Amneal · May 14, 2026
- ANDA214590Alembic · June 11, 2026
- ANDA218560Zydus Lifesciences · September 15, 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.
-
September 25, 2026 · Class III · Ongoing · D-0033-2027
Failed Impurities/Degradation Specifications
Tretinoin Cream USP, 0.05%, 45g tube, Rx only, Mfd by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-9. — SUN PHARMACEUTICAL INDUSTRIES INC
-
September 25, 2026 · Class III · Ongoing · D-0034-2027
Failed Impurities/Degradation Specifications
Tretinoin Cream USP, 0.05%, 45 g tube, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Product of Canada, NDC 16714-249-02. — SUN PHARMACEUTICAL INDUSTRIES INC
-
September 25, 2026 · Class III · Ongoing · D-0035-2027
Failed Impurities/Degradation Specifications
Tretinoin Cream UPS, 0.05%, 20g, Rx only, Mfd. by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1, Dist. by: Taro Pharmaceuticals USA Inc., Hawthorne, NY 10532, NDC 51672-1394-0. — SUN PHARMACEUTICAL INDUSTRIES 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
| RxCUI (RxNorm) | 106302, 106303, 198300, 199159, 208328, 208330, 208331, 208334, 245723, 252265 … (+10) |
|---|---|
| SPL set ID of the quoted label | 9556d73d-c573-4e0a-9feb-764ce2d1107b |
| FDA labels (SPL) | 56 |
| FDA applications | NDA017340, NDA017522, NDA017579, NDA017955, NDA019049, NDA020404, NDA020475, NDA021108, NDA022070, NDA209353, 25 ANDA |
| Active ingredients (FDA) | TRETINOIN |
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Retin-A, Bausch Health US, LLC, effective May 17, 2024; 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 →