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Class IIOngoing

Dicyclomine Hydrochloride Capsules recall

FDA recall D-0733-2026 · initiated Jul 23, 2026

By the pharmaranks editorial teamReviewed against the FDA (openFDA) sourcesUpdated Aug 12, 2026How we research

Aurobindo Pharma USA Inc recalled Dicyclomine Hydrochloride Capsules in Jul 2026 — an FDA Class II recall (D-0733-2026) because shortfill; reports of empty capsules.

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

shortfill; reports of empty capsules.

Another quality failure

A quality failure that does not fit the categories above.

This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.

Is your product affected? Check the lot number

A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.

Batch # DMC125018A, Exp Date: 07/2027.

Quantity recalled: 6,408 bottles distributed to market

Details

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
Recalling company
Aurobindo Pharma Limited
Classification
Class II
Status
Ongoing
Type
Voluntary: Firm initiated
Distribution
US Nationwide.
Initiated
Jul 23, 2026
FDA report date
Aug 12, 2026
What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Frequently asked

Was Dicyclomine Hydrochloride Capsules recalled?
Aurobindo Pharma USA Inc recalled Dicyclomine Hydrochloride Capsules in Jul 2026 — an FDA Class II recall (D-0733-2026) because shortfill; reports of empty capsules. May cause temporary or medically reversible harm; low probability of serious harm.
Why was Dicyclomine Hydrochloride Capsules recalled?
Per the FDA enforcement record, the reason for recall D-0733-2026 was: shortfill; reports of empty capsules.
Is a recalled Dicyclomine Hydrochloride Capsules dangerous to take?
An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
Which lots of Dicyclomine Hydrochloride Capsules are affected?
Distributed: US Nationwide.. The recall covers these lots — Batch # DMC125018A, Exp Date: 07/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0733-2026.

Source: openFDA Drug Enforcement record D-0733-2026

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