Exact FDA event identifier

Event 98477

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

Event summary

Timeline bucket: February 24, 2026
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: MYLAN PHARMACEUTICALS 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

Amnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.

D-0399-2026

Recall number: D-0399-2026
Initiated: February 24, 2026
Classification: Class II
Status: Ongoing
Recalling firm: MYLAN PHARMACEUTICALS INC
Quantity: 34850 blister packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lot #: 3116110, 3116130, Exp. Date 07/2026

Distribution pattern

Nationwide within the United States