FDA recall, , Moderate risk
Aurobindo Pharma Dicyclomine Hydrochloride Capsules
Dicyclomine Hydrochloride Capsules are shortfilled, with reports of empty capsules.
Summary by Recall Canary from the FDA notice
What happened
Aurobindo Pharma USA Inc, of East Windsor, New Jersey, is recalling Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, due to shortfill and reports of empty capsules. The company began the recall on July 23, 2026, and the FDA added it to its Enforcement Report on August 4, 2026. The product was distributed nationwide in the United States.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Dicyclomine Hydrochloride Capsules, USP, 10mg
- NDC
- 59651-719-99
- Lot code
- DMC125018A
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Aurobindo Pharma USA IncEast Windsor, New Jersey
- Hazard
- Quality problem
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99492
- Recall number
- D-0733-2026
- Quantity recalled
- 6,408 bottles distributed to market
All recalls from Aurobindo Pharma USA Inc
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
