Recall Ledger

Dicyclomine Hydrochloride Capsules recall (Aurobindo Pharma USA Inc)

DrugClass IIOngoing

Summary: Aurobindo Pharma USA Inc is recalling 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: shortfill; reports of empty capsules.

What is being recalled

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

Why

shortfill; reports of empty capsules.

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

US Nationwide.

How to tell if yours is affected

Batch # DMC125018A, Exp Date: 07/2027.

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0733-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedJuly 23, 2026
ReportedAugust 12, 2026
CompanyAurobindo Pharma USA Inc
Company locationEast Windsor, NJ, United States
Initiated byVoluntary: Firm initiated
Quantity6,408 bottles distributed to market

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