CLASS II Drug recall · Reported 21 May 2014 · FDA Enforcement Report
Glyburide and Metformin Hydrochloride Tablets USP, 5mg/500mg recalled
Teva Pharmaceuticals U is recalling Glyburide and Metformin Hydrochloride Tablets USP, 5mg/500mg, distributed nationwide in the US. The recall was initiated on 24 Mar 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-1293-2014
- FDA event ID
- 67811
- Recalling firm
- Teva Pharmaceuticals U, Horsham, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Mar 2014
- FDA classified
- 12 May 2014
- Reported
- 21 May 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Diabetes Medication
Timeline
| 24 Mar 2014 | Recall initiated by company | |
| 12 May 2014 | Classified by FDA | +49 days |
| 21 May 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
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Product as listed by the FDA
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05
Where it was distributed
Nationwide
Questions about this recall
Is Glyburide and Metformin Hydrochloride Tablets USP, 5mg/500mg recalled?
Yes. Teva Pharmaceuticals U recalled Glyburide and Metformin Hydrochloride Tablets USP, 5mg/500mg on 24 Mar 2014. The recall is Class II and its status is Terminated. Recall number D-1293-2014.
Why was it recalled?
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Which lots are affected?
TE36018, Exp. 06/15
Where was it sold?
Nationwide
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 21 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 Teva Pharmaceuticals U
All 196| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tretinoin Capsules, 10 mg recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS II | Doxylamine Succinate and Pyridoxine Hydrochloride recalledDoxylamine Succinate And Pyridoxine Hydrochloride | Teva Pharmaceuticals U | Potency & Assay | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS III | Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg recalledMimvey | Teva Pharmaceuticals U | Labeling Errors | Nationwide |
| Drug | CLASS II | Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Packaging Defects | Nationwide |