Moderate riskFDA DrugApr 15, 2026Class II

Teva isotretinoin capsules recalled for superpotency and subpotency

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.

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

What to do

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

Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product: 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).
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: 21984 packages
Illnesses reported: None reported
Manufactured in: 400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Classification: Class II
Recall number: D-0445-2026

In the FDA's words

Description: 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). Superpotent and Subpotent Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027 Distribution: FL, OH, PR & MS Affected quantity: 21984 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… (this page)
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…
D-0446-2026 · 8376 packages