fda_recall · drug_recall · high
Teva Pharmaceuticals USA, Inc — Class II recall: Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only…
- Event date
- 2024-04-17 00:00:00Z
- Observed
- 2026-07-16 23:20:07Z
- Source ID
- D-0439-2024
- Payload hash
- 52192c71971d009f4f418731…
Summary
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Status: Ongoing.
Entities
Frequently asked questions
- Has Teva Pharmaceuticals USA, Inc had other FDA enforcement actions?
- Yes. Argus HQ has recorded 41 total FDA actions tied to Teva Pharmaceuticals USA, Inc: 0 warning letters, 39 recalls, 2 approval records, and 0 Form 483 inspection citations.
- What kind of FDA record is this?
- This is an Argus HQ record of a FDA Recall, tagged high severity by Argus HQ. FDA published the underlying record on 2024-04-17; Argus observed and indexed it on 2026-07-16.
- Where can I verify this record directly with FDA?
- The verbatim FDA source record is the source of truth — Argus HQ links directly to it below. Always confirm against fda.gov before acting.
Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
APA
Argus HQ Research (2024). Teva Pharmaceuticals USA, Inc — Class II recall: Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only…. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0439-2024
MLA
"Teva Pharmaceuticals USA, Inc — Class II recall: Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only…." Argus HQ Research, Digital Empire Holdings LLC, 2024, argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0439-2024.
Chicago
Argus HQ Research. "Teva Pharmaceuticals USA, Inc — Class II recall: Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only…." Digital Empire Holdings LLC. Accessed July 23, 2026. https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0439-2024.
BibTeX
@misc{argushq_argushq_ai_events_fda_recall_teva_pharmaceuticals_usa_inc_d_0439_2024_2024,
title = {Teva Pharmaceuticals USA, Inc — Class II recall: Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only…},
author = {{Argus HQ Research}},
year = {2024},
publisher = {Digital Empire Holdings LLC},
url = {https://argushq.ai/events/fda-recall-teva-pharmaceuticals-usa-inc-d-0439-2024},
note = {Accessed: July 23, 2026}
}Informational only. Not legal, financial, or medical advice.

