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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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