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Aurobindo Pharma USA Inc: Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., 279 Princeton-Hightstown

DrugsSource: FDA (drug) · Date: 2026-08-12

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Aurobindo Pharma USA Inc
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 / hazard
shortfill; reports of empty capsules.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide.
Recall initiated
2026-07-23
Code info
Batch # DMC125018A, Exp Date: 07/2027.
Product quantity
6,408 bottles distributed to market
Voluntary mandated
Voluntary: Firm initiated
City
East Windsor
State
NJ
Country
United States
Event id
99492
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