DICYCLOMINE HYDROCHLORIDE
Generic: DICYCLOMINE HYDROCHLORIDE
Advagen Pharma Ltd.Manufacturer
ORALRoute
DICYCLOMINE HYDROCHLORIDEActive Substance
2026-07-17Original Approval
DICYCLOMINE HYDROCHLORIDE is FDA application ANDA216515, sponsored by RUBICON RESEARCH. 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 II2026-07-23
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Pshortfill; reports of empty capsules.
Class II2022-01-26
Dicyclomine Hydrochloride Tablets, USP 20 mg, 100 Tablets, Rx only, Manufactured For: Teva Pharmaceuticals USA, ParsippaCGMP Deviations: Products were exposed to temperatures outside of the products labeled storage condi
Top Reported Reactions
1
NAUSEA
343 reports
2
DIARRHOEA
325 reports
3
FATIGUE
318 reports
4
HEADACHE
302 reports
5
PAIN
247 reports
6
OFF LABEL USE
236 reports
7
DRUG INEFFECTIVE
235 reports
8
PRODUCT DOSE OMISSION ISSUE
234 reports
9
DIZZINESS
221 reports
10
COUGH
198 reports