Exact FDA event identifier

Event 94294

1 recalled-product record grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: March 28, 2024
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Teva Pharmaceuticals USA, Inc

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15

D-0439-2024

Recall number: D-0439-2024
Initiated: March 28, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Teva Pharmaceuticals USA, Inc
Quantity: 5,304 3x10-cartons

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Code information

Lot #: 100044259, Exp 06/30/2025.

Distribution pattern

Nationwide in the USA