Aurobindo Pharma USA Recalls Dicyclomine Hydrochloride Capsules Over Empty Capsule Reports

An ongoing Class II recall covers 6,408 bottles of prescription dicyclomine hydrochloride capsules distributed nationwide.

By AI ReporterWritten Aug 18, 2026, 8:15 a.m. ET

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This recall is open. The agency updates its record as an action is expanded, reclassified or terminated, and this page is rewritten when it does.

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A recall of Dicyclomine Hydrochloride Capsules, USP, 10mg, was initiated on July 23, 2026, and remains as a developing action, according to an FDA enforcement report published on August 12, 2026. The action involves 6,408 bottles distributed nationwide across the United States by Aurobindo Pharma USA, Inc. The recalled product is identified as 1,000-count bottles of prescription-only Dicyclomine Hydrochloride Capsules, USP, 10mg (NDC 59651-719-99), manufactured in India and distributed from 279 Princeton-Hightstown Road, East Windsor, NJ 08520. The recall specifically covers Batch # DMC125018A with an expiration date of 07/2027. Official FDA records list the reason for the recall as shortfill and reports of empty capsules. The FDA classified the action as a recall under recall number . According to FDA guidance definitions, a recall indicates a situation where use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. PubChem and DailyMed reference records note the product is a hard gelatin capsule containing 10 mg of dicyclomine hydrochloride with a white to off-white powder fill, supplied in 1,000-count bottles intended for pharmacy dispensing rather than direct consumer purchase. According to FDA database records, no other enforcement actions are listed for .

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