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Class II · ModerateActive recall

Dicyclomine Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberBatch # DMC125018A, Exp Date: 07/2027.
Where it was soldUS Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

shortfill; reports of empty capsules.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameDICYCLOMINE HYDROCHLORIDE
Generic nameDICYCLOMINE HYDROCHLORIDE
Active ingredient(s)DICYCLOMINE HYDROCHLORIDE
Distributed by / forAurobindo Pharma USA, Inc., 279 Princeton-Hightstown Road, East Windsor, NJ 08520
NDC59651-719-99
Show the full FDA record
Full product labelDicyclomine 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
Recalling firmAurobindo Pharma USA Inc
DistributionUS Nationwide.
Quantity6,408 bottles distributed to market
Recall initiated2026-07-23
Report date2026-08-12
Recall completed—
Recall numberD-0733-2026
ClassificationClass II
FDA statusOngoing
Origin on fileEast Windsor NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.