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Teva Pharmaceuticals USA, Inc: Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 070

DrugsSource: FDA (drug) · Date: 2026-04-15

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Teva Pharmaceuticals USA, Inc
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).
Reason / hazard
Superpotent and Subpotent
Classification
Class II
Status
Ongoing
Distribution / sold at
FL, OH, PR & MS
Recall initiated
2026-01-12
Code info
Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027
Product quantity
21984 packages
Voluntary mandated
Voluntary: Firm initiated
City
Parsippany
State
NJ
Country
United States
Event id
98275
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