HIGH

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...

Superpotent and Subpotent

Quick Facts at a Glance

Recall Date
January 12, 2026
Hazard Level
HIGH
Brands
ISOTRETINOIN, Actavis Pharma, Inc.
Geographic Scope
4 states

Hazard Information

Superpotent and Subpotent

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter

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Full 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).. Generic: ISOTRETINOIN; Brand: ISOTRETINOIN. Reason: Superpotent and Subpotent. Classification: Class II. Quantity: 21984 packages. Distribution: FL, OH, PR & MS

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lots 100055426
Exp. date 02/2026
100071518
Exp. date 04/2027 & 100072450
Exp. Date 07/2027
UPC Codes
0591-2433
0591-2434
0591-2451
+13 more
Affected States
FL, OH, PR, MS
Report Date
April 15, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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