Multi-event January 2024 FDA Recall Glimepiride by Dr. Reddy's Laboratories, Inc.
This Multi-event Class III drug recall was voluntarily initiated by Dr. Reddy's Laboratories, Inc. on January 18, 2024 for the product Glimepiride. The FDA reported the reason for recall as misprint on tablet. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0312-2024
Misprint on tablet
01-18-2024
02-14-2024
59,336 bottles
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
Batch or Lot Expiration Information
Lot# Lot: T2303622; Exp. 06/2026 Lot: T2303626; Exp. 06/2026 Lot: T2303627; Exp. 06/2026 Lot: T2303628; Exp. 06/2026 Lot: T2303629; Exp. 06/2026
Affected Packages Involved in this Recall
Recall Number: D-0313-2024
Misprint on tablet
01-18-2024
02-14-2024
14,425 bottles
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.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
Batch or Lot Expiration Information
Lot# Lot: T2303609; Exp. 06/2026 Lot: T2303610; Exp. 06/2026
