Benzonatate recalls

Benzonatate products have been recalled 4 times, most recently on 31 Jan 2024. The recalling company is usually Amerisource Health Services. The most common reason is packaging defects.

Total recalls4since 2014

Last 12 months0reported

Class I00% of total

Ongoing1latest 31 Jan 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 2 50%Class III 2 50%

Why benzonatate is recalled

Packaging Defects250%
Potency & Assay250%

Companies

By year

2024125%
2017125%
2015125%
2014125%

Ongoing benzonatate recalls

1 active

Reported	Class	Recall	Company	Reason	Where
31 Jan 2024Drug	CLASS III	Benzonatate Capsules, USP, 100 mg x dose cards) recalledBenzonatate	Amerisource Health Services	Potency & Assay	Nationwide

All benzonatate recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
31 Jan 2024Drug	CLASS III	Benzonatate Capsules, USP, 100 mg x dose cards) recalledBenzonatate	Amerisource Health Services	Potency & Assay	Nationwide
31 May 2017Drug	CLASS III	Benzonatate capsules, 200 mg recalled by Strides PharmaBenzonatate	Strides Pharma	Potency & Assay	Nationwide
8 Apr 2015Drug	CLASS II	Benzonatate Capsules, USP, 100 mg recalled by American Health PackagingBenzonatate	American Health Packaging	Packaging Defects	Nationwide
31 Dec 2014Drug	CLASS II	Benzonatate Capsules, USP, 100 mg recalled by Zydus Pharmaceuticals USABenzonatate	Zydus Pharmaceuticals USA	Packaging Defects	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.