Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000… was recalled on July 23, 2026 in cooperation with the U.S. Food and Drug Administration because shortfill; reports of empty capsules..
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 # DMC125018A, Exp Date: 07/2027.
Units affected: 6,408 bottles distributed to market
Where it was sold: US Nationwide.
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
shortfill; reports of empty capsules.
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Aurobindo Pharma USA Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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