Teva Pharmaceuticals recalls 40mg Isotretretinoin capsules due to superpotent and subpotent risks. Affected lots have specific expiration dates and packaging identifiers.
Superpotent and Subpotent
Teva Pharmaceuticals is recalling 40mg Isotretinoin capsules that may have superpotent or subpotent risks. This recall affects patients taking prescription acne treatment who may need to switch to a different product.
The capsules may contain inconsistent levels of active ingredient, potentially leading to either too high or too low doses. This could cause severe side effects or treatment failure.
Patients prescribed Isotretinoin for acne treatment who received the recalled capsules. Those with specific lot numbers and expiration dates are most at risk.
Check for the NDC codes 0591-2436-15 (carton) or 0591-2436-45 (blister pack). Look for lot numbers 100075305 (exp 06/2027), 100075512 (exp 07/2027), or 100076103 (exp 07/2027).
Identify the NDC codes and lot numbers to confirm if your capsules are affected.
The capsules may have superpotent or subpotent levels of active ingredient, which could lead to treatment failure or severe side effects.
Check for NDC codes 0591-2436-15 (carton) or 0591-2436-45 (blister pack) and lot numbers 100075305, 100075512, or 100076103 with specific expiration dates.
The recall does not specify a stop-use instruction, so you should check if your capsules are affected before taking them.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0446-2026 — Teva Teva Hello, I own a Teva that is covered by recall D-0446-2026 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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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.
