Glimepiride recalls: 8 FDA reports
Recalls involving Glimepiride. What was wrong with each batch, and how the FDA graded the risk.
8Reports
0Class I
4Ongoing
2024-02-14Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakula
D-0313-2024 · Class III · reported 2024-02-14 · Ongoing
- Why it was recalled
- Misprint on tablet
- Product
- Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05
- Where it went
- Nationwide
- How much
- 14,425 bottles
Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakula
D-0312-2024 · Class III · reported 2024-02-14 · Ongoing
- Why it was recalled
- Misprint on tablet
- Product
- Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01
- Where it went
- Nationwide
- How much
- 59,336 bottles
Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC
D-0551-2023 · Class II · reported 2023-05-03 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Glimepiride Tablets, USP 2mg, packaged in a) 30-count bottles (NDC 51655-383-52), and b)90-count bottles (NDC 51655-383-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
- Where it went
- Nationwide with the United States
- How much
- a) 230 bottles; b) 22 bottles
Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC
D-0552-2023 · Class II · reported 2023-05-03 · Ongoing
- Why it was recalled
- CGMP Deviations
- Product
- Glimepiride Tablets, USP 4mg, packaged in a) 30-count bottles (NDC 51655-120-52), and b) 90-count bottles (NDC 51655-120-26), Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203.
- Where it went
- Nationwide with the United States
- How much
- a) 198 bottles; b) 22 bottles
Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4
D-0393-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-count bottle NDC 16729-001-16 UPC 3 16729 00116 8; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Where it went
- United States including Puerto Rico and Canada
- How much
- 469,944 bottles
Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 5
D-0394-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 Tablets NDC 16729-002-16 UPC 3 16729 00216 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA
- Where it went
- United States including Puerto Rico and Canada
- How much
- 992,622 bottles
Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8;
D-0395-2023 · Class II · reported 2023-03-08 · Terminated
- Why it was recalled
- CGMP Deviations: recalling drug products following an FDA inspection.
- Product
- 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
- Where it went
- United States including Puerto Rico and Canada
- How much
- 1,158,839 bottles
GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05)
D-0046-2015 · Class II · reported 2014-11-05 · Terminated
- Why it was recalled
- Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
- Product
- GLIMEPIRIDE TABLETS, USP 2 mg, a)100 count bottle, (NDC 42571-101-01), b) 500 count Bottle (NDC 42571-101-05), Rx only, Manufactured by: Micro Labs Limited, Goa-403 722, INDIA, Manufactured for: Micro Labs USA, Inc., Princeton, NJ 08540
- Where it went
- CT, FL, MD, MS, NY
- How much
- 11,328 bottles
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All drug recalls