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Drug Class II · moderate Ongoing

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

shortfill; reports of empty capsules.

Recalling firmAurobindo Pharma USA Inc
Reasonshortfill; reports of empty capsules.
Risk classClass II (Class II · moderate)
StatusOngoing
Report dateAug 12, 2026
InitiatedJul 23, 2026
RegionNJ, United States
DistributionUS Nationwide.
Quantity6,408 bottles distributed to market
Code/LotBatch # DMC125018A, Exp Date: 07/2027.
TypeVoluntary: Firm initiated
Recall numberD-0733-2026

Official source

U.S. FDA — Recalls, Market Withdrawals & Safety Alerts fda.gov ↗

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