October 2024 FDA Recall Drug by Dr. Reddy's Laboratories, Inc.
D-0047-2025 - Failed Tablet/Capsule Specifications
This Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on October 29, 2024 for the product Drug. The FDA reported the reason for recall as failed tablet/capsule specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0047-2025
Failed Tablet/Capsule Specifications
10-29-2024
11-27-2024
3416 botttles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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.
Dr. Reddy's Laboratories, 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.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05
Batch or Lot Expiration Information
Lot# : C5406201, Exp 03/31/2028
