Medications & Supplements/Prescription Drugs

Amnesteem (Isotretinoin) Capsules Recalled for Failed Dissolution

Agency Publication Date: March 4, 2026

Summary

Mylan Pharmaceuticals Inc. is voluntarily recalling 34,850 blister packs of Amnesteem (isotretinoin) capsules, USP 40 mg. The recall was initiated because the medication failed to meet dissolution specifications, which means the capsules may not dissolve properly in the body. This issue could affect how much medication is absorbed. No incidents or injuries have been reported to date. This medication was distributed nationwide to pharmacies.

Risk

If the capsules do not dissolve correctly, the medication may not be fully absorbed into the bloodstream, potentially reducing the effectiveness of the treatment for severe acne.

What You Should Do

Check your medication packaging for Amnesteem (Isotretinoin) Capsules, USP 40 mg, specifically looking for NDC 0378-6614-93.
Locate the lot number and expiration date printed on the prescription pack. This recall affects lot numbers 3116110 and 3116130, both with an expiration date of 07/2026.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Amnesteem (Isotretinoin) Capsules (3 x 10-Count Prescription Packs)

Variants: 40 mg

Lot Numbers:

3116110 (Exp. 07/2026)

3116130 (Exp. 07/2026)

NDC:

0378-6614-93

Recall #: D-0399-2026; Rx Only; Manufactured for Mylan Pharmaceuticals Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 98477

Status: Active

Manufacturer: MYLAN PHARMACEUTICALS INC

Sold By: pharmacies

Manufactured In: France, United States

Units Affected: 34850 blister packs

Distributed To: Nationwide

Agency Last Updated: March 31, 2026

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your medication packaging for Amnesteem (Isotretinoin) Capsules, USP 40 mg, specifically looking for NDC 0378-6614-93.

Locate the lot number and expiration date printed on the prescription pack. This recall affects lot numbers 3116110 and 3116130, both with an expiration date of 07/2026.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.