July 2026 FDA Recall Dicyclomine Hydrochloride by Aurobindo Pharma Usa Inc
D-0733-2026 - shortfill; reports of empty capsules.
This Class II drug recall was voluntarily initiated by Aurobindo Pharma Usa Inc on July 23, 2026 for the product Dicyclomine Hydrochloride. The FDA reported the reason for recall as shortfill; reports of empty capsules.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0733-2026
shortfill; reports of empty capsules.
07-23-2026
08-12-2026
6,408 bottles distributed to market
Recall Profile & Regulatory Data
Class II - is a situation in which 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Aurobindo Pharma USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Batch# DMC125018A, Exp Date: 07/2027.
