NDC 16729-003

Glimepiride 4 mg tablet

On the label: Accord Healthcare Inc..

Where it's made

Recalls

• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) R2000166, Exp. Date 4/30/2023, P2003528 Exp. Date 6/30/2023, P2005451 Exp. Date 8/31/2023, P2005438 Exp. Date 8/31/2023, P2005436 Exp. Date 8/31/2023, P2005437 Exp. Date 8/31/2023, P2005452 Exp. Date 8/31/2023, P2006055 Exp. Date 9/30/2023, P2101782 Exp. Date 2/28/2024, P2101783 Exp. Da…
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: 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. …
• Feb 7, 2023 · Class II · Accord Healthcare, Inc.
  CGMP Deviations: recalling drug products following an FDA inspection.
  Lots: Batches: a) P2001868, Exp. Date 3/31/2023, P2001869 Exp. Date 3/31/2023, P2002810 Exp. Date 5/31/2023, P2005473 Exp. Date 8/31/2023, P2005552 Exp. Date 9/30/2023, P2101986 Exp. Date 3/31/2024, P2101989 Exp. Date 3/31/2024, P2101988 Exp. Date 3/31/2024, P2101991 Exp. Date 3/31/2024, P2101992 Exp. Da…

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Glimepiride: every company that makes it

Form

tablet, oral

Strength

4 mg

Approval

ANDA ANDA078181

On the market since

Aug 23, 2007

Package NDCs

16729-003-01 16729-003-16 16729-003-17

Official label

DailyMed (National Library of Medicine), updated Oct 17, 2025

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