Severity
Moderate
FDA Drug recall · Reported May 21, 2014
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Teva Pharmaceuticals USA recalled GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactu… - a moderate-severity action.
GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactu… was recalled by Teva Pharmaceuticals USA in May 21, 2014. Reason: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements. Check the official notice for the remedy. Verify recall #D-1293-2014 with the FDA Drug before acting.
The recall
Teva Pharmaceuticals USA issued this moderate-severity FDA Drug recall-CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Sourced from official FDA Drug enforcement records. Verify recall #D-1293-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Drug action (record #D-1293-2014) was formally reported on May 21, 2014, with the manufacturer initiating the action on March 24, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Teva Pharmaceuticals USA is listed as the recalling firm, operating out of Horsham, PA. Federal records list the affected scope as 2532 bottles.
The documented reason for this recall is: CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 3,731 children & baby products recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
2532 bottles
Related Recalls
6
0 from same agency
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
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1293-2014 |
| Date reported | May 21, 2014 |
| Date initiated | March 24, 2014 |
| Recalling firm | Teva Pharmaceuticals USA |
| Firm location | Horsham, PA |
| Affected scope | 2532 bottles |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 21, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.