Quick answers
- What is Amnesteem?
- Amnesteem is a brand name of Isotretinoin, a prescription medicine. The FDA NDC Directory lists 4 Amnesteem products in 4 strengths and forms.
- Who makes Amnesteem?
- Mylan Pharms Inc holds the FDA application for Amnesteem (ANDA075945, approved November 8, 2002).
- Is there a generic or store brand of Amnesteem?
- Yes. The FDA NDC Directory lists 39 other products with the same active ingredients, strength and form as a Amnesteem product, 35 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Amnesteem?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 4 Amnesteem strengths and forms (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Amnesteem been recalled?
- FDA enforcement reports list 1 recall of Amnesteem products; the newest started February 24, 2026. A recall usually concerns specific lots, not every product.
What Amnesteem is
Each Amnesteem product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Isotretinoin · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| isotretinoin 10 mg capsule (oral) | Amnesteem | 9 products, 6 companies | DailyMed |
| isotretinoin 20 mg capsule (oral) | Amnesteem | 10 products, 6 companies | DailyMed |
| isotretinoin 30 mg capsule (oral) | Amnesteem | 10 products, 6 companies | DailyMed |
| isotretinoin 40 mg capsule (oral) | Amnesteem | 10 products, 6 companies | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Isotretinoin →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA075945 | Mylan Pharms Inc | November 8, 2002 | 4 |
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: Amnesteem | $1.96 per capsule Generic of the same strength and form: $1.96–$4.21 per capsule |
| isotretinoin 20 mg capsule | Generic: Amnesteem | $1.93 per capsule Generic of the same strength and form: $1.93–$4.18 per capsule |
| isotretinoin 30 mg capsule | Generic: Amnesteem | $2.01 per capsule Generic of the same strength and form: $2.01–$5.43 per capsule |
| isotretinoin 40 mg capsule | Generic: Amnesteem | $2.19 per capsule Generic of the same strength and form: $2.19–$5.83 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 Amnesteem
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Amnesteem products.
- Mylan Pharmaceuticals Inc.4 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
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
Sources
- 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 labeling (SPL, 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
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.