Teva recalls 40mg Isotretretinoin capsules due to potential stability issues affecting drug potency. Learn about affected lots and what to do.
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Teva is recalling 40mg Isotretinoin capsules that may have stability issues. This could affect the drug's potency, but the recall does not indicate immediate safety risks to users.
The drug's stability test results showed it was above the acceptable limit for potency over a 3-month period. This means the medication might not be as effective as intended when taken.
Prescription users of Teva's 40mg Isotretinoin capsules with lot number 100044259. Those who have the specific packaging details listed in the recall are most at risk.
Check for blister packs labeled NDC 0591-2436-45 and cartons with NDC 0591-2436-15. The lot number 100044259 and expiration date of 06/30/2025 are also key identifiers.
Look for the blister pack NDC 0591-2436-45 and carton NDC 0591-2436-15 with lot number 100044259.
The recall is due to potential stability issues that could affect potency, but there are no immediate safety risks reported.
Check the product details to see if it matches the recalled lot number and packaging. If it does, contact Teva for further instructions.
Look for the specific NDC numbers and lot number listed in the recall notice.
We’ve drafted a message you can send Teva to request your refund or repair — edit it as you like.
Subject: Recall D-0439-2024 — Teva Teva Hello, I own a Teva that is covered by recall D-0439-2024 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.
