FDAFDA recall D-0733-2026 · Aug 12, 2026
Aurobindo Pharma USA Inc: Dicyclomine Hydrochloride Capsules recall
Recall found
Product
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
Reason for recall
shortfill; reports of empty capsules.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Batch # DMC125018A, Exp Date: 07/2027.
- Quantity
- 6,408 bottles distributed to market
- Distribution
- US Nationwide.
- Recalling firm
- Aurobindo Pharma USA Inc, East Windsor, NJ
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-23
Source: openFDA enforcement record D-0733-2026 · search recall number D-0733-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.