FDA-Drug2026-04-15Class II

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).

Teva Pharmaceuticals USA, Inc
Hazard
Superpotent and Subpotent
Sold states
FL, OH, PR & MS
Affected count
21984 packages
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Products
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).

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0445-2026

Original summary

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). Superpotent and Subpotent Lots 100055426, Exp. date 02/2026, 100071518, Exp. date 04/2027 & 100072450, Exp. Date 07/2027 Distribution: FL, OH, PR & MS Affected quantity: 21984 packages

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