The Recall Desk
ModerateFDA (Drugs)·D-0394-2023·Announced 2023-03-08

Glimepiride 2 mg tablets recalled for manufacturing practice deviations

Accord Healthcare recalls Glimepiride 2 mg tablets distributed in the US, Puerto Rico, and Canada due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. Approximately 992,622 bottles across multiple batches are affected.

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: FDA Class II precautionary recall based on manufacturing procedure deviations identified during facility inspection; no reported illnesses, injuries, or confirmed product contamination documented in the source.

Plain-English summary

Accord Healthcare, Inc. is recalling Glimepiride Tablets USP, 2 mg, distributed throughout the United States, Puerto Rico, and Canada. The recall affects approximately 992,622 bottles across multiple production batches with expiration dates ranging from April 2023 to July 2025, in both 100-tablet and 500-tablet package sizes.

The FDA identified deviations from Current Good Manufacturing Practice (CGMP) standards during an inspection of the manufacturing facility. These deviations pertain to manufacturing procedures and quality control measures at the production site.

Patients currently taking Glimepiride should consult their healthcare provider or pharmacist to determine whether their medication is included in this recall. The specific batch numbers and expiration dates of affected products are available through the official FDA drug recalls database.

The recalled product

Product
GLIMEPIRIDE (GLIMEPIRIDE)
Brand
GLIMEPIRIDE
Manufacturer
Accord Healthcare, Inc.
Category
Drug
Hazard
  • manufacturing-deficiency

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 (20)

  • Batches: a) R2000184
  • Exp. Date 4/30/2023
  • R2000183 Exp. Date 4/30/2023
  • P2002969 Exp. Date 5/31/2023
  • P2002970 Exp. Date 5/31/2023
  • P2005346 Exp. Date 8/31/2023
  • P2005847 Exp. Date 10/31/2023
  • P2006133 Exp. Date 10/31/2023
  • P2100682 Exp. Date 1/31/2024
  • P2102065 Exp. Date 3/31/2024
  • P2102067 Exp. Date 3/31/2024
  • P2102068 Exp. Date 3/31/2024
  • P2102070 Exp. Date 3/31/2024
  • R2100659 Exp. Date 5/31/2024
  • R2100660 Exp. Date 5/31/2024
  • P2103898 Exp. Date 6/30/2024
  • P2106000 Exp. Date 7/31/2024
  • R2101442 Exp. Date 9/30/2024
  • P2201160 Exp. Date 1/31/2025
  • P2200695 Exp. Date 1/31/2025

UPCs (4)

  • 0316729003018
  • 0316729002011
  • 316729002011
  • 316729002165

Distribution

Distribution scope not specified by the agency.

Related recalls

Same brand · GLIMEPIRIDE

Same category