CLASS II Drug recall · Reported 5 Nov 2014 · FDA Enforcement Report
Glimepiride Tablets, USP 2 mg, a) recalled by Micro Labs Usa, Inc S
Micro Labs Usa Inc S is recalling Glimepiride Tablets, USP 2 mg, a), (, distributed in Connecticut, Florida, Maryland, Mississippi, New York. The recall was initiated on 9 Oct 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0046-2015
- FDA event ID
- 69133
- Recalling firm
- Micro Labs Usa Inc S, Princeton, NJ
- Brand
- Glimepiride
- Manufacturer
- Micro Labs Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Oct 2014
- FDA classified
- 27 Oct 2014
- Reported
- 5 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 9 Oct 2014 | Recall initiated by company | |
| 27 Oct 2014 | Classified by FDA | +18 days |
| 5 Nov 2014 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 was distributed
CT, FL, MD, MS, NY
Questions about this recall
Why was it recalled?
Failed Stability Specifications: Micro Labs is recalling two lots due to out of specification results during stability testing.
Which lots are affected?
GLBG001 Exp.12/14, GLBG008 Exp. 06/15
Where was it sold?
CT, FL, MD, MS, NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Micro Labs Usa Inc S
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Simvastatin Tablets, USP, 80mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa Inc S | Potency & Assay | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 20mg a) bottle (42517-0020-10) recalled | Micro Labs Usa Inc S | Potency & Assay | Nationwide |
| Drug | CLASS III | Simvastatin Tablets, USP, 40mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa Inc S | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets USP, 25 mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa Inc S | Other | NY |
| Drug | CLASS III | Simvastatin Tablets, USP, 10 mg recalled by Micro Labs Usa, Inc S | Micro Labs Usa Inc S | Potency & Assay | NY |
Other Glimepiride recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's LaboratoriesGlimepiride | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS III | Glimepiride Tablets, USP 1mg recalled by Dr. Reddy's LaboratoriesGlimepiride | Dr. Reddy's Laboratories | Other | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP, 1 mg, RX, Packaged as a) recalled | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) recalled | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) recalled | Amerisource Health Services | Manufacturing (CGMP) Deviations | Nationwide |