Why it was recalled
shortfill; reports of empty capsules.
Product description
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
Lot numbers, UPCs & expiration codes
Batch # DMC125018A, Exp Date: 07/2027.
Where it was sold
US Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0733-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 23, 2026
- FDA report date
- Aug 12, 2026
- Quantity
- 6,408 bottles distributed to market
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc
Original FDA data
Every field from FDA enforcement report D-0733-2026, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 99492
- Address
- 279 Princeton Hightstown Rd
- Code information
- Batch # DMC125018A, Exp Date: 07/2027.
- Postal code
- 08520-1401
- Report date
- Aug 12, 2026
- Product type
- Drugs
- Recall number
- D-0733-2026
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc
- Product quantity
- 6,408 bottles distributed to market
- Reason for recall
- shortfill; reports of empty capsules.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jul 23, 2026
- Initial firm notification
- Letter
- Center classification date
- Aug 4, 2026