D-0446-2026Class II

Teva Pharmaceuticals USA, Inc

Recalling firm

Product type

Drug

Status

Ongoing

Report date

2026-04-15

Distribution

FL, OH, PR & MS

Firm state

Product quantity

8376 packages

Initiated by

Voluntary: Firm initiated

SPEQ quality domain

Validation & Qualification

Reason for recall

Superpotent and Subpotent

Product 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).

Code / lot info

Lots 100075305 Exp date 06/2027, 100075512, Exp date 07/2027 & 100076103, Exp date 07/2027 .

Other recalls SPEQ maps to Validation & Qualification

2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc 2026-07-22Class IIBell Pharmaceuticals, Inc

See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.