Medications & Supplements/Prescription Drugs

Teva Isotretinoin Capsules Recalled for Being Superpotent

Agency Publication Date: April 8, 2024

Summary

Teva Pharmaceuticals USA, Inc. is recalling 5,304 cartons of Isotretinoin Capsules, USP 40mg, a medication used to treat severe acne. Testing revealed that the drug is superpotent, meaning it contains more of the active ingredient than the required specification limit. The recall affects 30-count cartons containing blister packs with lot number 100044259 and an expiration date of June 30, 2025.

Risk

Taking medication that is stronger than intended can increase the risk and severity of side effects associated with isotretinoin. Because this drug already has a high risk of significant side effects, exposure to higher-than-prescribed doses poses a medium health risk to consumers.

What You Should Do

The recalled product is Teva Isotretinoin Capsules, USP 40mg, sold in cartons of 30 capsules (three 10-count blister packs per carton). The cartons are labeled with NDC 0591-2436-15 and the individual blister packs are labeled with NDC 0591-2436-45.
Check your medication packaging for lot number 100044259 with an expiration date of 06/30/2025 to see if your supply is affected.
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 Teva Pharmaceuticals USA, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) 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: Isotretinoin Capsules, USP 40mg (30-count)

Variants: 40mg, Capsule

Lot Numbers:

100044259 (Exp 06/30/2025)

NDC:

0591-2436-45

0591-2436-15

30-count 3x10 blister packs per carton. Manufactured for Teva Pharmaceuticals USA, Inc.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94294

Status: Active

Manufacturer: Teva Pharmaceuticals USA, Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 5,304 3x10-cartons

Distributed To: Nationwide

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

The recalled product is Teva Isotretinoin Capsules, USP 40mg, sold in cartons of 30 capsules (three 10-count blister packs per carton). The cartons are labeled with NDC 0591-2436-15 and the individual blister packs are labeled with NDC 0591-2436-45.

Check your medication packaging for lot number 100044259 with an expiration date of 06/30/2025 to see if your supply is affected.

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 Teva Pharmaceuticals USA, Inc. for further instructions.

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