FDA-Drug2026-04-15Class IIMISBRANDING
Teva Isotretinoin 30 mg capsules recalled for potency inconsistency
Stop using Teva Isotretinoin 30 mg capsules
Teva Pharmaceuticals is recalling specific lots of Isotretinoin 30 mg capsules because some capsules may contain too much active ingredient (superpotent) while others may contain too little (subpotent). This inconsistency could affect how well the medication works or increase the risk of side effects.
- Check if your Isotretinoin matches lot numbers 100055426, 100071518, or 100072450
- Contact your pharmacy or doctor immediately if you have one of these lots
- Do not stop taking your medication without talking to your doctor first
- Your doctor can provide a replacement or alternative treatment
Hazard
Superpotent and Subpotent
Sold states
FL, OH, PR & MS
Affected count
21984 packages
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2026More 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 40 mg capsules recalled for inconsistent strength
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