ISOTRETINOIN
Generic: ISOTRETINOIN
Upsher-Smith LaboratoriesManufacturer
ORALRoute
ISOTRETINOINActive Substance
2021-04-12Original Approval
ISOTRETINOIN is FDA application ANDA213571, sponsored by UPSHER SMITH LABS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2024-03-28
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva PharmaceuticalSuperpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II2026-01-12
Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc.Superpotent and Subpotent
Class III2019-10-16
Isotretinoin Capsules, USP 10 mg. Rx Only, 3 Prescription Blister Packs of 10- Capsules Each (30 Capsules)-. DistributedFailed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits.
Class II2026-01-12
Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc.Superpotent and Subpotent
Top Reported Reactions
1
PREGNANCY
1,037 reports
2
DEPRESSION
1,018 reports
3
EXPOSURE DURING PREGNANCY
717 reports
4
ABORTION INDUCED
684 reports
5
ADVERSE DRUG REACTION
628 reports
6
PRODUCT DOSE OMISSION ISSUE
581 reports
7
DRY SKIN
559 reports
8
HEADACHE
558 reports
9
ARTHRALGIA
543 reports
10
SUICIDAL IDEATION
521 reports