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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86520

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

Open FDA event record

Event summary

Timeline bucket
October 02, 2020
Product types
Drug
Classifications
Class III
Statuses
Terminated
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

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

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

D-0049-2021
Recall number
D-0049-2021
Initiated
October 02, 2020
Classification
Class III
Status
Terminated
Quantity
10,695 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Out-of-specification organic impurity results obtained during routine stability testing.

Code information

Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021

Distribution pattern

Nationwide within the United States