ISOTRETINOIN
Recalling Firm / Manufacturer: Teva Pharmaceuticals USA, Inc
(Parsippany, NJ, United States)
FDA Recall Number: D-0446-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
ISOTRETINOIN
Generic Name
ISOTRETINOIN
Active Substance(s)
Isotretinoin
Administration Route
Oral
National Drug Code (NDC)
0591-2433
Total Quantity Recalled
8376 packages
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Superpotent and Subpotent
Full Product Description
Packaging specifications and labeling details
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).
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
April 15, 2026
Firm Initiation Date
January 12, 2026
FDA Classification Date
Apr 08, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .
Distribution Information
Geographic scope of affected shipments
FL, OH, PR & MS
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0446-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508604UTCC