Benzonatate recalls

The FDA has published 7 recalls involving Benzonatate since 2014. The latest was reported on 31 Jan 2024. Most were for packaging defects. Zydus Pharmaceuticals USA has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls7since 2014

Last 12 months0reported

Class I114% of total

Ongoing1latest 31 Jan 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 14%Class II 3 43%Class III 3 43%

Why benzonatate is recalled

Companies

By year

2024114%
2022114%
2017114%
2015114%
2014343%

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

7 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
1 Jun 2022Drug	CLASS I	Benzonatate capsules, 100mg recalled by Calvin Scott & Company	Calvin Scott & Company	Packaging Defects	GA
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
24 Dec 2014Drug	CLASS II	Benzonatate Capsules, USP, 200 mg recalled by Zydus Pharmaceuticals USA	Zydus Pharmaceuticals USA	Packaging Defects	Nationwide
10 Dec 2014Drug	CLASS III	Benzonatate Capsules, USP, 200 mg recalled by Zydus Pharmaceuticals USA	Zydus Pharmaceuticals USA	Other	Nationwide

Should you stop taking Benzonatate?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.