CLASS II ONGOING Drug recall · Reported 12 Aug 2026 · FDA Enforcement Report
Dicyclomine Hydrochloride Capsules, USP, 10mg recalled
Aurobindo Pharma USA is recalling Dicyclomine Hydrochloride Capsules, USP, 10mg, distributed nationwide in the US. The recall was initiated on 23 Jul 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0733-2026
- FDA event ID
- 99492
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Manufacturer
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 Jul 2026
- FDA classified
- 4 Aug 2026
- Reported
- 12 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 23 Jul 2026 | Recall initiated by company | |
| 4 Aug 2026 | Classified by FDA | +12 days |
| 12 Aug 2026 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
shortfill; reports of empty capsules.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India, NDC 59651-719-99
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
shortfill; reports of empty capsules.
Which lots are affected?
Batch # DMC125018A, Exp Date: 07/2027.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Aurobindo Pharma USA
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|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 60mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Dicyclomine recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| 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 |