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D-0733-2026Class II

Aurobindo Pharma USA Inc

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Aurobindo Pharma USA Inc
Product type
Drug
Status
Ongoing
Report date
2026-08-12
Distribution
US Nationwide.
Firm state
NJ
Product quantity
6,408 bottles distributed to market
Initiated by
Voluntary: Firm initiated
Reason for recall

shortfill; reports of empty capsules.

Product description

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

Code / lot info

Batch # DMC125018A, Exp Date: 07/2027.

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →