Medications & Supplements/Prescription Drugs

BluePoint Glimepiride Tablets Recalled for Quality Standards Deviations

Agency Publication Date: May 19, 2023

Summary

Amerisource Health Services LLC is recalling approximately 298,545 bottles of Glimepiride (glimepiride) tablets under the BluePoint Laboratories brand. This recall was initiated due to manufacturing quality deviations discovered during an FDA inspection at the production facility in India. No illnesses or adverse health incidents have been reported to date, but the recall aims to ensure patients do not use medication that failed to meet federal safety and quality standards.

Risk

These manufacturing deviations can compromise the quality and safety of the medication. When a drug is manufactured outside of strict quality guidelines, it may not work correctly or could pose unexpected risks to patients managing their blood sugar levels.

What You Should Do

This recall affects BluePoint Laboratories Glimepiride (glimepiride) tablets in 1 mg, 2 mg, and 4 mg strengths, sold in 100-count and 500-count bottles.
Identify your medication by checking the NDC number and lot code on the bottle. Affected NDC numbers include 68001-177-00, 68001-177-03 (1 mg), 68001-178-00, 68001-178-03 (2 mg), and 68001-179-00, 68001-179-03 (4 mg). See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amerisource Health Services LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Glimepiride Tablets, USP (1 mg)by BluePoint Laboratories

Variants: 1 mg, 100-count bottle, 500-count bottle

Lot Numbers:

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)

P2100095 (EXP 11/30/2023)

P2100624 (EXP 01/31/2024)

P2101780 (EXP 02/29/2024)

P2107383 (EXP 09/30/2024)

P2201505 (EXP 02/28/2025)

R2201109 (EXP 06/30/2025)

NDC:

68001-177-00

68001-177-03

Manufactured by Intas Pharmaceuticals Limited for BluePoint Laboratories.

Product: Glimepiride Tablets, USP (2 mg)by BluePoint Laboratories

Variants: 2 mg, 100-count bottle, 500-count bottle

Lot Numbers:

P2003493 (EXP 05/31/2023)

P2100120 (EXP 11/30/2023)

P2100683 (EXP 01/31/2024)

P2106002 (EXP 07/31/2024)

R2200148 (EXP 12/31/2024)

R2201125 (EXP 06/30/2025)

P2003403 (EXP 05/31/2023)

P2005800 (EXP 09/30/2023)

P2101156 (EXP 01/31/2024)

P2105401 (EXP 07/31/2024)

R2200083 (EXP 12/31/2024)

R2201004 (EXP 07/31/2025)

NDC:

68001-178-00

68001-178-03

Manufactured by Intas Pharmaceuticals Limited for BluePoint Laboratories.

Product: Glimepiride Tablets, USP (4 mg)by BluePoint Laboratories

Variants: 4 mg, 100-count bottle, 500-count bottle

Lot Numbers:

P2003403 (EXP 05/31/2023)

P2006593 (EXP 11/30/2023)

P2101152 (EXP 01/31/2024)

P2105014 (EXP 06/30/2024)

R2101440 (EXP 09/30/2024)

P2200774 (EXP 01/31/2025)

R2200664 (EXP 04/30/2025)

P2100705 (EXP 01/31/2024)

P2104672 (EXP 06/30/2024)

R2101435 (EXP 09/30/2024)

R2200102 (EXP 12/31/2024)

R2200577 (EXP 04/30/2025)

P2205870 (EXP 08/31/2025)

P2100121 (EXP 11/30/2023)

R2200577 (EXP R2200577)

NDC:

68001-179-00

68001-179-03

Manufactured by Intas Pharmaceuticals Limited for BluePoint Laboratories.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92058

Status: Resolved

Manufacturer: Amerisource Health Services LLC

Sold By: BluePoint Laboratories; Amerisource Health Services LLC

Manufactured In: India

Units Affected: 3 products (63,335 bottles; 105,361 bottles; 129,849 bottles)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects BluePoint Laboratories Glimepiride (glimepiride) tablets in 1 mg, 2 mg, and 4 mg strengths, sold in 100-count and 500-count bottles.

Identify your medication by checking the NDC number and lot code on the bottle. Affected NDC numbers include 68001-177-00, 68001-177-03 (1 mg), 68001-178-00, 68001-178-03 (2 mg), and 68001-179-00, 68001-179-03 (4 mg). See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amerisource Health Services LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Glimepiride Tablets, USP (1 mg)by BluePoint Laboratories

Variants: 1 mg, 100-count bottle, 500-count bottle

Lot Numbers:

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)

P2100095 (EXP 11/30/2023)

P2100624 (EXP 01/31/2024)

P2101780 (EXP 02/29/2024)

P2107383 (EXP 09/30/2024)

P2201505 (EXP 02/28/2025)

R2201109 (EXP 06/30/2025)

NDC:

68001-177-00

68001-177-03

Manufactured by Intas Pharmaceuticals Limited for BluePoint Laboratories.

Product: Glimepiride Tablets, USP (2 mg)by BluePoint Laboratories

Variants: 2 mg, 100-count bottle, 500-count bottle

Lot Numbers:

P2003493 (EXP 05/31/2023)

P2100120 (EXP 11/30/2023)

P2100683 (EXP 01/31/2024)

P2106002 (EXP 07/31/2024)

R2200148 (EXP 12/31/2024)

R2201125 (EXP 06/30/2025)

P2003403 (EXP 05/31/2023)

P2005800 (EXP 09/30/2023)

P2101156 (EXP 01/31/2024)

P2105401 (EXP 07/31/2024)

R2200083 (EXP 12/31/2024)

R2201004 (EXP 07/31/2025)

NDC:

68001-178-00

68001-178-03

Manufactured by Intas Pharmaceuticals Limited for BluePoint Laboratories.

Product: Glimepiride Tablets, USP (4 mg)by BluePoint Laboratories

Variants: 4 mg, 100-count bottle, 500-count bottle

Lot Numbers:

P2003403 (EXP 05/31/2023)

P2006593 (EXP 11/30/2023)

P2101152 (EXP 01/31/2024)

P2105014 (EXP 06/30/2024)

R2101440 (EXP 09/30/2024)

P2200774 (EXP 01/31/2025)

R2200664 (EXP 04/30/2025)

P2100705 (EXP 01/31/2024)

P2104672 (EXP 06/30/2024)

R2101435 (EXP 09/30/2024)

R2200102 (EXP 12/31/2024)

R2200577 (EXP 04/30/2025)

P2205870 (EXP 08/31/2025)

P2100121 (EXP 11/30/2023)

R2200577 (EXP R2200577)

NDC:

68001-179-00

68001-179-03

Manufactured by Intas Pharmaceuticals Limited for BluePoint Laboratories.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92058

Status: Resolved

Manufacturer: Amerisource Health Services LLC

Sold By: BluePoint Laboratories; Amerisource Health Services LLC

Manufactured In: India

Units Affected: 3 products (63,335 bottles; 105,361 bottles; 129,849 bottles)

Distributed To: Nationwide