Moderate riskFDA DrugApr 15, 2026Class II

Teva isotretinoin 40 mg capsules recalled for potency problems

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.

From the FDA notice · Read the official notice ↗ · All Teva recalls

What to do

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

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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).
Sold in: FL, OH, PR & MS
Made for: Adults (0 months and older)

This recall covers 2 products — see all of them.

Details

Units affected: 8376 packages
Illnesses reported: None reported
Manufactured in: 400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Classification: Class II
Recall number: D-0446-2026

In the FDA's words

Description: 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). Superpotent and Subpotent Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 . Distribution: FL, OH, PR & MS Affected quantity: 8376 packages
Hazard: Superpotent and Subpotent

2 products in this recall

Teva isotretinoin capsules recalled for potency errors

Teva is recalling two strengths of isotretinoin capsules, 30 mg and 40 mg, because some capsules may be stronger or weaker than the labeled amount. The recall covers 10-count prescription packs distributed in Florida, Ohio, Puerto Rico and Mississippi, and no injuries have been reported.

The agency lists each product separately. Check every one you might have.

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435…
D-0445-2026 · 21984 packages
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436… (this page)
D-0446-2026 · 8376 packages