FDA Recalls Glimepiride Tablets for Misprint on Tablet
Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets due to a misprint on the tablet. The recall affects 59,336 bottles distributed nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a labeling issue (misprint on tablet) rather than a dosing or safety-critical defect, consistent with the rubric classification of minor labeling errors as Moderate (2).
Plain-English summary
Dr. Reddy's Laboratories, Inc. is recalling Glimepiride Tablets, USP 1mg, 100-count bottles (NDC: 55111-320-01) due to a misprint on the tablet. The affected lots are T2303622, T2303626, T2303627, T2303628, and T2303629, all with an expiration date of 06/2026.
This is a voluntary recall initiated by the manufacturer. A total of 59,336 bottles have been distributed nationwide. The misprint on the tablet affects the product's printed identifying information, which is critical for ensuring proper medication identification and use.
Consumers and healthcare providers who have this medication should contact Dr. Reddy's Laboratories or their pharmacy to determine if they have the affected lots. Patients should not discontinue this medication without consulting their healthcare provider, as abruptly stopping this diabetes medication could be harmful.
The recalled product
- Product
- GLIMEPIRIDE (GLIMEPIRIDE)
- Brand
- GLIMEPIRIDE
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Category
- Drug
- Hazard
- Affected units
- 59,336
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Dr. Reddy's Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same brand · GLIMEPIRIDE
- ModeratePrescription Glimepiride Tablets Recalled Due to Tablet Misprint
FDA (Drugs) · 2024-02-14
- ModerateFDA Recalls Glimepiride Tablets for Manufacturing Deviations
FDA (Drugs) · 2023-05-03
- ModeratePrescription Drug Glimepiride Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2023-05-03
- ModerateGlimepiride 2 mg tablets recalled for manufacturing practice deviations
FDA (Drugs) · 2023-03-08
- HighAccord Healthcare recalls Glimepiride tablets due to manufacturing practice deviations
FDA (Drugs) · 2023-03-08
Same manufacturer · Dr. Reddy's Laboratories, Inc.
See all →- ModerateVarenicline tablets recalled after an assay value fell below specification
FDA (Drugs) · 2025-12-17
- Moderate
- HighOmeprazole capsule bottle contained a foreign divalproex sodium tablet
FDA (Drugs) · 2025-07-23
- SevereLevetiracetam Injection Label Mismatch Nationwide Recall
FDA (Drugs) · 2025-04-23
- ModerateFDA Recalls JAVYGTOR Tablets Due to Failed Impurities and Degradation Specifications
FDA (Drugs) · 2024-12-18
Same hazard · mis labeling
See all →- ModerateAllies Group Recalls Subpotent SPF 50 Sunscreen Gel Sachets
FDA (Drugs) · 2026-09-09
- HighPrince Bakery Recalls Italian and French Bread for Undeclared Sesame
FDA (Food) · 2026-09-09
- LowB Braun Recalls Discofix Stopcock Sets Due to Incorrect Expiration Date
FDA (Devices) · 2026-09-09
- ModerateWonton Skin Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09
- ModerateWonton Specialist Cooked Noodle Recalled for Undeclared Red Dye
FDA (Food) · 2026-09-09