FDA-Drug2026-04-15Class IIMISBRANDING
Teva Isotretinoin 40 mg capsules recalled for inconsistent strength
Stop using Teva Isotretinoin 40 mg capsules
Teva Pharmaceuticals is recalling certain batches of Isotretinoin 40 mg capsules because some capsules may be too strong (superpotent) or too weak (subpotent). This medication is a prescription acne treatment that requires precise dosing. The affected batches were distributed in Florida, Ohio, Puerto Rico, and Mississippi.
- Contact your pharmacy or prescriber if you have one of the affected lots (100075305, 100075512, or 100076103)
- Do not stop taking Isotretinoin without talking to your doctor
- Ask your pharmacist to verify your prescription is not from a recalled batch
Hazard
Superpotent and Subpotent
Sold states
FL, OH, PR & MS
Affected count
8376 packages
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0446-2026More Teva Pharmaceuticals USA, Inc recalls
- FDA-Drug2026-04-29Teva Claravis (isotretinoin) 10 mg recalled for elevated tretinoin impurity levels
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.2 mg/day recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.1 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Clonidine Transdermal System 0.3 mg recalled for unapproved raw material
- FDA-Drug2026-04-15Teva Isotretinoin 30 mg capsules recalled for potency inconsistency
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