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FDA · Drugs ·

Isotretinoin Capsules recall

Teva Pharmaceuticals USA, Inc recalled Isotretinoin Capsules on April 15, 2026 because of superpotent and Subpotent. It was sold in FL, OH, PR, MS.

Why it was recalled

Superpotent and Subpotent

What's recalled

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

Quantity: 8376 packages

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Teva Pharmaceuticals USA, Inc, Parsippany, NJ
Date
Severity
Class II
the product could cause temporary or reversible health problems.
Where sold
FL, OH, PR, MS
FL, OH, PR & MS
Status
Ongoing
Recall number
D-0446-2026
Source
U.S. Food and Drug Administration

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