Dicyclomine recalls
The FDA has published 4 recalls involving Dicyclomine since 2014. The latest was reported on 12 Aug 2026. Most were for labeling errors. Aurobindo Pharma 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 recalls4since 2014
Last 12 months1reported
Class I00% of total
Ongoing2latest 12 Aug 2026
Recalls per month, last 24 months
click a bar for that monthSeverity split
Class I 0 0%Class II 4 100%Class III 0 0%
Why dicyclomine is recalled
Companies
By year
Ongoing dicyclomine recalls
2 active| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Dicyclomine Hydrochloride Injection USP, 20 mg/ (10 mg/mL) ampules recalled | Akorn | Potency & Assay | Nationwide |
All dicyclomine recalls, newest first
4 total| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Dicyclomine Hydrochloride Tablets, USP 20 mg recalledDicyclomine Hydrochloride | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Dicyclomine Hydrochloride Injection USP, 20 mg/ (10 mg/mL) ampules recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Dicyclomine HCL, Tablet, 20 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
Should you stop taking Dicyclomine?
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.