FDA recall D-0446-2026

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).

Reason for recall

Superpotent and Subpotent

Distribution

FL, OH, PR & MS

Key facts

Status

Ongoing

Initiation date

2026-01-12

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Parsippany, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0446-2026