Prescription Drug Isotretinoin Recalled Due to Over-Potent Formulation
Teva Pharmaceuticals recalls Isotretinoin 40mg capsules for exceeding specification limits in potency. No illnesses reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a prescription drug found to exceed active ingredient specification limits. While no illnesses or injuries have been reported, the risk from a superpotent formulation of a high-risk medication justifies High severity per the rubric.
Plain-English summary
Teva Pharmaceuticals USA, Inc. has recalled one lot of Isotretinoin Capsules, USP 40mg (Lot #100044259, expiring 06/30/2025). During 3-month stability testing, the drug's assay was found to exceed the specification limit, resulting in a superpotent formulation.
The recalled product consists of 5,304 cartons distributed nationwide in the USA with NDC 0591-2436-45 (blister pack) and 0591-2436-15 (carton). No illnesses or injuries have been reported to date.
The recalled product
- Product
- ISOTRETINOIN (ISOTRETINOIN)
- Brand
- ISOTRETINOIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 100044259
- Exp 06/30/2025.
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ISOTRETINOIN
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 30 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- LowAmneal Recalls Isotretinoin Capsules Due to Tretinoin Impurity Levels
FDA (Drugs) · 2019-11-20
Same manufacturer · Teva Pharmaceuticals USA, Inc
See all →- ModerateTeva Recalls Metoclopramide Tablets Due to Foreign Object Presence
FDA (Drugs) · 2026-10-21
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
- SevereOctreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
FDA (Drugs) · 2026-05-13
- ModerateClaravis isotretinoin 10 mg capsules recalled for out-of-specification impurity
FDA (Drugs) · 2026-04-29
- ModerateTeva clonidine 0.3 mg patches recalled over unapproved raw material use
FDA (Drugs) · 2026-04-15
Same hazard · superpotency
See all →- CriticalVitruvias Recalls Superpotent Thyroid Tablets Nationwide
FDA (Drugs) · 2026-09-23
- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
Similar recalls
- HighTeva isotretinoin 40 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- HighTeva isotretinoin 30 mg capsules recalled as superpotent and subpotent
FDA (Drugs) · 2026-04-15
- ModerateTeva Recalls Amoxicillin Oral Suspension Due to Potency Issues
FDA (Drugs) · 2016-08-31
- HighPrescription testosterone gel recalled due to out-of-specification potency
FDA (Drugs) · 2022-08-03
- ModerateTeva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures
FDA (Drugs) · 2016-10-12
- HighTestosterone Gel Recalled by Teva for Excessive Potency
FDA (Drugs) · 2024-08-28