Class II FDA drug recall · D-0395-2023

Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.

This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.

Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-count NDC 16729-003-16 UPC 3 16729 00316 2; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA

Why it was recalled

CGMP Deviations: recalling drug products following an FDA inspection.

The recall was initiated by Accord Healthcare, Inc. (the firm that distributes or relabels it); the product is made by Accord Healthcare Inc. That is normal — the distributor, not always the maker, files the recall.

Is your unit affected?

The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.

A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.

Show the FDA's listed lot / code information

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. Date 3/31/2024, R2100736 Exp. Date 6/30/2024, R2100737 Exp. Date 6/30/2024, P2105281 Exp. Date 7/31/2024, R2101441 Exp. Date 9/30/2024, R2101454 Exp. Date 10/31/2024, R2101455 Exp. Date 10/31/2024, R2101468 Exp. Date 10/31/2024, R2101469 Exp. Date 10/31/2024, R2200096 Exp. Date 12/31/2024; b)P2005550, Exp. Date 9/30/2023, P2005549 Exp. Date 9/30/2023, P2005551 Exp. Date 9/30/2023, P2005812 Exp. Date 10/31/2023, P2005813 Exp. Date 10/31/2023, P2005970 Exp. Date 10/31/2023, P2005971 Exp. Date 10/31/2023, P2005974 Exp. Date 10/31/2023, P2005814 Exp. Date 10/31/2023, P2005972 Exp. Date 10/31/2023, P2005973 Exp. Date 10/31/2023, P2005998 Exp. Date 10/31/2023, P2005999 Exp. Date 10/31/2023, P2006001 Exp. Date 10/31/2023, P2005997 Exp. Date 10/31/2023, P2006000 Exp. Date 10/31/2023, P2100701 Exp. Date 1/31/2024, P2100702 Exp. Date 1/31/2024, P2100703 Exp. Date 1/31/2024, P2100704 Exp. Date 1/31/2024, P2102512 Exp. Date 3/31/2024, P2101993 Exp. Date 3/31/2024, P2101994 Exp. Date 3/31/2024, P2102951 Exp. Date 4/30/2024, P2102952 Exp. Date 4/30/2024, P2102953 Exp. Date 4/30/2024, P2102954 Exp. Date 4/30/2024, R2100739 Exp. Date 6/30/2024, R2100738 Exp. Date 6/30/2024, R2100740 Exp. Date 6/30/2024, P2104668 Exp. Date 6/30/2024, P2104669 Exp. Date 6/30/2024, P2104670 Exp. Date 6/30/2024, P2105283 Exp. Date 7/31/2024, P2105291 Exp. Date 7/31/2024, P2105282 Exp. Date 7/31/2024, P2105794 Exp. Date 7/31/2024, P2105292 Exp. Date 7/31/2024, P2105297 Exp. Date 7/31/2024, P2105293 Exp. Date 7/31/2024, P2105295 Exp. Date 7/31/2024, P2105294 Exp. Date 7/31/2024, R2101408 Exp. Date 9/30/2024, R2101409 Exp. Date 9/30/2024, R2101410 Exp. Date 9/30/2024, R2101411 Exp. Date 9/30/2024, R2101412 Exp. Date 9/30/2024, R2101413 Exp. Date 9/30/2024, R2200089 Exp. Date 12/31/2024, R2200097 Exp. Date 12/31/2024, R2200100 Exp. Date 12/31/2024, R2200101 Exp. Date 12/31/2024, R2200088 Exp. Date 12/31/2024, P2200775 Exp. Date 1/31/2025, P2200776 Exp. Date 1/31/2025, P2201221 Exp. Date 1/31/2025, P2201347 Exp. Date 2/28/2025, P2201348 Exp. Date 2/28/2025, R2200481 Exp. Date 3/31/2025, R2200576 Exp. Date 4/30/2025, P2203378 Exp. Date 5/31/2025, P2203379 Exp. Date 5/31/2025, P2203377 Exp. Date 5/31/2025, R2200966 Exp. Date 6/30/2025, R2200964 Exp. Date 6/30/2025, R2200973 Exp. Date 6/30/2025, P2204893 Exp. Date 8/31/2025

Recall status

Terminated — the FDA has closed the recall; the firm's corrective actions were judged effective.

Where it was distributed

United States including Puerto Rico and Canada

Recall record

Recalling firm: Accord Healthcare, Inc.
Manufacturer: Accord Healthcare Inc
Brand name: GLIMEPIRIDE
Generic name: GLIMEPIRIDE
Product type: Drugs
Recall number: D-0395-2023
Voluntary / mandated: Voluntary: Firm initiated
Initial notification: Letter
Origin: Durham, NC
Recall initiated: 2023-02-07
Terminated: 2024-04-22

What to do

Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.

Also available: structured data (JSON-LD) · recall record (JSON)

What this is — and is not

A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.

To report a problem you experienced, use FDA MedWatch. Verify this record at FDA recalls · Recall D-0395-2023 · Source: openFDA enforcement.