Glimepiride Tablet
FDA Recall NDC 55111-321
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Glimepiride (NDC 55111-321). A significant event, classified as Class III, was initiated on Jan 18, 2024 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Misprint on tablet"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class III Ongoing
Misprint on tablet
Jan 18, 2024
Feb 14, 2024
59,336 bottles
Recall Profile & Regulatory Data
Event ID
93833
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
55111-320-30Product
55111-320-01Product
55111-320-05Product
55111-320-79Product
55111-320-78Product
55111-321-30Product
55111-321-01Product
55111-321-05Product
55111-321-79Product
55111-321-78Product
55111-322-30Product
55111-322-01Product
55111-322-05Product
55111-322-79Product
55111-322-78Product
Class III Ongoing
Misprint on tablet
Jan 18, 2024
Feb 14, 2024
14,425 bottles
Recall Profile & Regulatory Data
Event ID
93833
Classification
Class III
Enforcement Status
Ongoing
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Product Description
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
Affected Packages Involved in this Recall
55111-320-30Product
55111-320-01Product
55111-320-05Product
55111-320-79Product
55111-320-78Product
55111-321-30Product
55111-321-01Product
55111-321-05Product
55111-321-79Product
55111-321-78Product
55111-322-30Product
55111-322-01Product
55111-322-05Product
55111-322-79Product
55111-322-78Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
