“Teva Isotretinoin Capsules 40mg Recall: Stability Issue.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32753-teva-isotretinoin-capsules-40mg-recall-stability-issue. Based on FDA recall #D-0439-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0439-2024%22&limit=1).
The FDA announced on March 28, 2024, that Teva Pharmaceuticals USA, Inc. is recalling Isotretinoin Capsules, USP 40mg due to assay results exceeding specification limits. The agency issued recall number D-0439-2024 for the voluntary Class II action.
How to tell if you have it
Brand: Teva
Product: Isotretinoin Capsules, USP 40mg
Packaging: 30-count 3x10 blister packs per carton
Blister Pack NDC: 0591-2436-45
Carton NDC: 0591-2436-15
Lot #: 100044259
Expiration Date: 06/30/2025
Quantity: 5,304 cartons
The hazard
The recall addresses a stability result for assay found to be above the specification limit at three months. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include Teva recalling traZODone 50mg tablets on August 24, 2026, and Teva Octreotide Acetate 30mg Kit on April 24, 2026. Cipla issued recalls for Nilotinib 200mg Capsules and Phytonadione Injectable Emulsion in February and October 2025 respectively due to stability issues.
How to tell if you have this one
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.
Brand
Teva
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the blister pack NDC 0591-2436-45 and carton NDC 0591-2436-15 with lot number 100044259.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 20 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0439-2024 (March 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0439-2024 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.