The FDA announced on July 23, 2026, that Aurobindo Pharma USA Inc is recalling Dicyclomine Hydrochloride Capsules due to shortfill and reports of empty capsules. The agency issued recall number D-0733-2026 for the Class II voluntary recall.
How to tell if you have it
- Brand: Aurobindo Pharma
- Product: Dicyclomine Hydrochloride Capsules, USP, 10mg
- NDC: 59651-719-99
- Batch #: DMC125018A
- Exp Date: 07/2027
- Quantity: 1,000 bottles per unit; 6,408 total bottles distributed
The hazard
The recall addresses shortfill issues and reports of empty capsules within the product. The FDA classified this as a Class II recall.
Context
GovInfoNow's records show Aurobindo Pharma USA Inc has 32 other recalls on record since April 9, 2013. In May 2025, the company recalled Acetaminophen Tablets due to brown tablet discoloration risk caused by cGMP deviations. Other recent recalls of similar products include ANI Pharmaceuticals Estradiol Gel (May 12, 2026), Asclemed Duloxetine Capsules (May 14, 2026), and Golden State Medical Prasugrel HCl Tablets (August 21, 2026).