Prescription medicine
Tretinoin Brand names: Retin-A, Altreno, Atralin, Renova
Tretinoin (Retin-A) is a prescription medicine with an FDA approval on record since 1971. FDA's NDC Directory lists it from 23 generic labelers, and pharmacies paid $0.506 per gram (Tretinoin 0.025% cream) in the October 7, 2026 NADAC survey.
- Generic listed
Check it at the source: the tretinoin FDA label on DailyMed (effective May 17, 2024, Bausch Health US, LLC); the NDA 16921 record on Drugs@FDA; every tretinoin label on DailyMed.
Highlights of the record
FDA label of May 17, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageRETIN-A is indicated for topical application in the treatment of acne vulgaris.
Forms and strengths
- 10 mg
- 0.05 g/100g
- 0.1 mg/g
- 0.2 mg/g
- 0.25 mg/g
- 0.4 mg/g
- 0.5 mg/g
- 0.6 mg/g
- 0.8 mg/g
- 1 mg/g
Cream; gel; capsule; lotion.
On the market
- Earliest approval on file
- October 20, 1971 Retin-A, Valeant Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 33 first June 19, 1998; 25 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 28 of which 23 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- August 22, 2038 Altreno lotion; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $0.506 per gram Tretinoin 0.025% cream
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 2 since 2022 0 Class I among all firms' recalls; latest June 14, 2022
- FAERS reports
- 8,069 through July 30, 2026
What is tretinoin used for?
From the label: indications and usageRETIN-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.
Conditions named in the indications of tretinoin's FDA labels, with every medicine labeled for each:
From other tretinoin labelsAcne: INDICATIONS AND USAGE RETIN-A is indicated for topical application in the treatment of acne vulgaris.
FDA pharmacologic class: Retinoid.
Source: FDA drug label (Retin-A), Bausch Health US, LLC, effective May 17, 2024 (SPL set 9556d73d-c573-4e0a-9feb-764ce2d1107b), via openFDA; the full label on DailyMed
Is there a generic for tretinoin (Retin-A)?
The FDA approved the first generic tretinoin on June 19, 1998. 33 generic applications are approved; 25 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 tretinoin from 23 labelers under a generic (ANDA) application and from 3 brand labelers. 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 Retin-A Micro gel; a patent listed only for Altreno lotion runs to August 22, 2038. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 1971 earliest approval on file
- 1998 first generic approved
- 2038 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 tretinoin (Retin-A)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.506 per gram (Tretinoin 0.025% cream), down 49% from $0.993 on October 8, 2025. The survey records the price, not the reason for a change; large moves often follow a new generic or a list-price change. 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.
- Tretinoin 0.025% cream (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tretinoin 0.01% gel | Generic | $2.52 per gram | n/a | -10% |
| Tretinoin 0.025% cream | Generic | $0.506 per gram | n/a | -49% |
| Tretinoin 0.025% gel | Generic | $3.03 per gram | n/a | +11% |
| Tretinoin 0.05% cream | Generic | $1.33 per gram | n/a | -9% |
| Tretinoin 0.05% gel | Generic | $3.93 per gram | n/a | -6% |
| Tretinoin 0.1% cream | Generic | $0.845 per gram | n/a | -30% |
| Tretinoin 10 mg capsule | Generic | $8.53 per capsule | $255.93 | -32% |
| Tretinoin gel micro 0.08% pump | Generic | $11.46 per gram | n/a | -4% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has tretinoin been recalled?
The FDA's Enforcement Report lists 2 recalls naming tretinoin since 2022: 0 Class I (the most serious), 2 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| June 14, 2022 | Class II | Teva Pharmaceuticals USA Inc | Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. |
| January 10, 2022 | Class II | Teva Pharmaceuticals USA | Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution. |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tretinoin label say about other medicines?
The tretinoin label names 2 other medicines in its interaction, contraindication or warning sections. The labels of 4 other medicines name tretinoin. 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 |
|---|---|---|
| Benzoyl peroxide | warnings and precautions | Advise patients that concomitant use of topical over the counter (OTC) acne products containing benzoyl peroxide, sulfur, resorcinol, or salicylic acid with RETIN-A MICRO may increase the risk for local skin irritation including dryness, erythema, and peeling. |
| Salicylic acid | drug interactions | Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with RETIN-A. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of RETIN-A is begun. |
Other labels that name tretinoin
Source: FDA drug label (Retin-A), Bausch Health US, LLC, effective May 17, 2024 (SPL set 9556d73d-c573-4e0a-9feb-764ce2d1107b), via openFDA; the full label on DailyMed
What do FAERS reports show for tretinoin?
The FDA Adverse Event Reporting System holds 8,069 reports that list tretinoin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 864 are coded as a death and 1,669 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 tretinoin?
13 other medicines are given the same way (topical) and in the same FDA class as tretinoin or labeled mainly for the same use (acne), the same class first. Acne lists all 26 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (topical) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Adapalene | Acne | 34 labelers | $0.504 per gram 0.3% gel | No current entry |
| Adapalene and benzoyl peroxide | Acne | 11 labelers | $0.626 per gram 0.3-2.5% | No current entry |
| Tazarotene | Acne | 6 labelers | $6.11 per gram 0.1% gel | No current entry |
| Adapalene and benzoyl peroxide and clindamycin | Acne | none listed | n/a | No current entry |
| Trifarotene | Acne | none listed | $16.36 per gram 0.005% cream | No current entry |
| Salicylic acid | Acne | none listed | $0.102 per patch Callus removers patch | No current entry |
| Benzoyl peroxide | Acne | none listed | $0.0469 per gram 10% wash | No current entry |
| Sulfur | Acne | none listed | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does tretinoin compare with medicines for the same use?
9 side-by-side pages set tretinoin beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to tretinoin
- 13 medicines for the same use
- Other retinoids
- the pharmacologic class, with prices and generics
- Tretinoin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other