FDA Drugs recall ·

Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only… recall

Recall number
D-0733-2026
Date
(initiated July 23, 2026)
Company / brand
Aurobindo Pharma USA Inc
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
6,408 bottles distributed to market
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

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

Why was it recalled?

shortfill; reports of empty capsules.

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Batch # DMC125018A, Exp Date: 07/2027.

Distribution

US Nationwide.

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0733-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.