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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92636

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

Open FDA event record

Event summary

Timeline bucket
July 05, 2023
Product types
Drug
Classifications
Class II
Statuses
Terminated
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

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

Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx only, Manufactured By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0093-8199-28

D-0913-2023
Recall number
D-0913-2023
Initiated
July 05, 2023
Classification
Class II
Status
Terminated
Quantity
180 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Failed Moisture Limits: Water (moisture) content above the approved product specifications.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Moisture Limits: Water (moisture) content above the approved product specifications.

Code information

Lot # 100037220, Exp 10/2024

Distribution pattern

Product was distributed to 3 wholesalers/distributors who further distributed the product Nationwide in the USA.