BENZONATATE
Generic: BENZONATATE
Bionpharma Inc.Manufacturer
ORALRoute
BENZONATATEActive Substance
1993-01-29Original Approval
BENZONATATE is FDA application ANDA081297, sponsored by BIONPHARMA. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class III2017-05-09
Benzonatate capsules, 200 mg, 100-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bangaluru -560076 IndiaFailed Stability Specifications: Out of Specification results obtained for preservative Methylparabe
Class III2023-12-26
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American HeSuperpotent drug: Assay results were slightly above specification at the time zero point.
Class II2015-01-06
Benzonatate Capsules, USP, 100 mg, 100 count (10X10), Rx only, Packaged and Distributed by: American Health Packaging CoFailed Tablet/Capsule Specifications; recall initiated by manufacturer due to reports of wet capsule
Class II2014-12-23
Benzonatate Capsules, USP, 100 mg, Rx only, Manufactured by: Cadila Healthcare Ltd, Ahmedabad, India; Distributed by: ZFailed Tablet/Capsule Specifications: Recall due to wet and/or leaking capsules.
Top Reported Reactions
1
FATIGUE
1,263 reports
2
COUGH
1,237 reports
3
CHRONIC KIDNEY DISEASE
1,234 reports
4
DYSPNOEA
1,180 reports
5
DIARRHOEA
1,126 reports
6
PNEUMONIA
1,120 reports
7
NAUSEA
1,100 reports
8
PAIN
940 reports
9
RENAL FAILURE
871 reports
10
HEADACHE
845 reports