Teva Isotretinoin Capsules 30mg Recall: Superpotent and Subpotent Risk

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Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Teva Pharmaceuticals is recalling 30mg Isotretinoin capsules that may have superpotent or subpotent levels. This could lead to serious health risks if taken incorrectly. The recall affects specific lots with expiration dates through July 2027.

Why it’s dangerous

The capsules may contain levels of isotretinoin that are too high (superpotent) or too low (subpotent) compared to the intended dose. This could cause serious health issues if taken without proper medical supervision.

Who’s affected

Prescription users of Teva's 30mg Isotretinoin capsules with specific lot numbers and expiration dates. Those who have the affected lots are most at risk.

How to tell if you have this one

Check the product label for the lot numbers 100055426 (expiring 02/2026), 100071518 (expiring 04/2027), or 100072450 (expiring 07/2027). The product is a 10-count prescription pack with NDC codes 0591-2435-15 or 0591-2435-45.

Brand
Teva
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot numbers 100055426, 100071518, or 100072450 on the packaging.

✎ GovInfoNow

Questions people ask

What is the hazard with these capsules?

The capsules may have superpotent or subpotent levels of isotretinoin, which could cause serious health risks if taken incorrectly.

Which lots are affected?

Lots 100055426 (expiring 02/2026), 100071518 (expiring 04/2027), and 100072450 (expiring 07/2027).

Is there a remedy for this recall?

The recall notice does not specify any remedy.

Take action

Contact Teva

We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall D-0445-2026 — Teva Teva

Hello,

I own a Teva that is covered by recall D-0445-2026 from Teva.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0445-2026 (January 12, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0445-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA,

Recall notice