Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0757-2023·Announced 2023-05-31

Nationwide Recall of Glimepiride Tablets for Manufacturing Practice Deviations

Amerisource Health Services LLC recalls 63,335 bottles of Glimepiride Tablets nationwide due to manufacturing practice deviations identified during FDA inspection.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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: FDA Class II recall for manufacturing practice deviations without reported illnesses, injuries, or hospitalizations. The hazard is a manufacturing or quality control deficiency rather than a specific identified contaminant or defect.

Plain-English summary

Amerisource Health Services LLC is recalling 63,335 bottles of Glimepiride Tablets, USP, 1 mg nationwide. The recall includes both 100-count bottles (NDC# 68001-177-00) and 500-count bottles (NDC# 68001-177-03) manufactured by Intas Pharmaceuticals Limited in India.

The U.S. Food and Drug Administration identified deviations from Current Good Manufacturing Practice (CGMP) during an inspection. These manufacturing practice deviations prompted the recall of affected batches with various expiration dates identified by the FDA.

Consumers who have been prescribed this medication should speak with their healthcare provider or pharmacist about the recall for guidance on next steps.

The recalled product

Product: Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories
Manufacturer: Amerisource Health Services LLC
Category: Drug — Antidiabetic
Hazard: manufacturing-defect
Affected units: 63,335

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 (19)

Batches a) P2002616
EXP 04/30/2023
P2006509
EXP 11/30/2023
P2103572
EXP 04/30/2024
P2106811
EXP 09/30/2024
R2200578
EXP 04/30/2025 b)P2100095
P2100624
EXP 01/31/2024
P2101780
EXP 02/29/2024
P2107383
P2201505
EXP 02/28/2025
R2201109
EXP 06/30/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Amerisource Health Services LLC 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 3 products in this recall →

Same manufacturer · Amerisource Health Services LLC

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