Z-1382-2021Class II

SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA

Name: Z-1382-2021 SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Creator: Sunstar Americas, Inc.
Published: 2021-03-23
License: https://open.fda.gov/license/

Sunstar Americas, Inc. / initiated 2021-03-23 / Terminated / root cause: manufacturing process

FDA source

Sunstar Americas, Inc. began a recall of SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA on 2021-03-23. FDA classified it as Class II and gives the reason as "Product may be contaminated with Burkholderia contaminans". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1382-2021
Classification: Class II
Status: Terminated
Initiated: 2021-03-23
Posted: 2021-04-09
Terminated: 2023-08-28
Recalling firm: Sunstar Americas, Inc.
Product: SUNSTAR Butler Clear Dip, 16 FL OZ, SKU #716PA
Product code: EAX Mirror, Mouth
Reason for recall: Product may be contaminated with Burkholderia contaminans.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Sunstar initiated the recall by letter and email on 03/23/2021. The letter requested the consignee check their inventory and isolate affected product, then contact customer service with the results. The firm requested the return of the product. Distributors are asked to notify their customers down to the user level.
Quantity in commerce: 19471 bottles
Distribution: US and Taiwan, Thailand, Malaysia, Japan, Hong Kong, Mexico
Product codes and lots: Lot Numbers; 532952, 535180, 536513, 536514, 539487, 551038, 551039

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1382-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1382-2021	Class II	Terminated	Voluntary: Firm initiated	2021-04-21	2021-04-09

Product code EAX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)