Z-2148-2016Class III

Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)

Name: Z-2148-2016 Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
Creator: GSK Consumer Healthcare
Published: 2016-04-25
License: https://open.fda.gov/license/

Haleon US HOLDINGS LLC / initiated 2016-04-25 / Terminated / root cause: labeling and UDI

FDA source

GSK Consumer Healthcare began a recall of Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ) on 2016-04-25. FDA classified it as Class III and gives the reason as "Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2148-2016
Classification: Class III
Status: Terminated
Initiated: 2016-04-25
Posted: 2016-07-11
Terminated: 2017-07-19
Recalling firm: Haleon US HOLDINGS LLC
Product: Breathe Right Clear, 30 ct. carton., UPC 7-57145-00246-7 (US), UPC 9-300673-871749 (AU/NZ)
Product code: N/A
Reason for recall: Some cartons used in the secondary packaging of Breathe Right Clear, Large, 30 ct. Nasal Strips were incorrectly labeled for cartons intended for the AU/NZ market.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: GSK Consumer Healthcare sent an Urgent - Product Recall Letter dated April 4, 2016, to all affected customers and an updated recall letter dated April 25, 2016, via FedEx. The recall letters identified the product and problem. The April 25, 2016, was sent to further clarify, the lot number on the Breathe Right carton. The customers were asked to immediately examine their inventory, quarantine and cease distribution of the specific lot of the affected product. Customers were asked to carry out a physical count and record the data on the response form. The response form should be returned to GSK within five (5) business days, even if you do not have the recalled lot. The response form should be faxed to (336) 499-8795. If customer needs shipping assistance or questions about the recall process, they can call 1-844-722-2104, and refer to Event Number 535STRIPS16. If any customer has questions, they can direct them to GSK Consumer Healthcare Consumer Relations team at 800-858-6673.
Quantity in commerce: 1,440 cases ( 34, 560 retail - units )
Distribution: US Nationwide
Product codes and lots: Shipper case lot #8008580, Retal Carton Lot #4543U8008580

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2148-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2148-2016	Class III	Terminated	Voluntary: Firm initiated	2016-07-20	2016-07-11

Product code N/A

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)