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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84261

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

Open FDA event record

Event summary

Timeline bucket
November 15, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Akorn, 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

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

MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.

D-0647-2020
Recall number
D-0647-2020
Initiated
November 15, 2019
Classification
Class II
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
4,206 boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Mispackaging

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.

Code information

Lot V20M54A, Exp 01/2021

Distribution pattern

Nationwide in the USA and Puerto Rico