Dicyclomine Hydrochloride Capsule
FDA Recall NDC 59651-719
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Dicyclomine Hydrochloride (NDC 59651-719). A significant event, classified as Class II, was initiated on Jul 23, 2026 by Aurobindo Pharma Limited. The reported reason for this action was: "shortfill; reports of empty capsules."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
shortfill; reports of empty capsules.
Jul 23, 2026
Aug 12, 2026
6,408 bottles distributed to market
Recall Profile & Regulatory Data
Event ID
99492
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Aurobindo Pharma USA Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US Nationwide.
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
Batch or Lot Expiration Information
Batch# DMC125018A, Exp Date: 07/2027.
Affected Packages Involved in this Recall
59651-719-01Product
59651-719-99Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
