Teva Pharmaceuticals
Overview
Teva Pharmaceuticals is a leading global pharmaceutical company that develops, produces, and markets affordable generic drugs and specialty pharmaceuticals. The company is committed to improving the lives of patients by providing high-quality, cost-effective healthcare solutions.
Therapeutic areas
API / Drug Master Files
Teva Pharmaceuticals holds 0 active (9 total) FDA Type II Drug Master Files — identifying it as an active-substance / API supplier. Type II DMFs are filed with the FDA to support the use of an active pharmaceutical ingredient in drug applications.
- AMOXICILLIN SODIUMInactive2005-04-08
- CEFACLOR USPInactive1999-11-19
- CEPHRADINEInactive1998-09-01
- CEFAZOLIN SODIUMInactive1998-09-01
- CYCLACILLINInactive1998-09-01
- CLOXACILLIN SODIUMInactive1998-09-01
- OXACILLIN SODIUMInactive1998-09-01
- PENICILLIN V POTASSIUMInactive1998-04-30
- CEPHALOSPORIN GInactive1990-07-11
FDA compliance signals
50 FDA enforcement records linked to this company.
- recall — Class II2026-05-13
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- recall — Class II2026-04-29
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
- recall — Class II2026-04-15
Superpotent and Subpotent
- recall — Class II2026-04-15
CGMP Deviations: use of an unapproved raw material
- recall — Class II2026-04-15
CGMP Deviations: use of an unapproved raw material
- recall — Class II2026-04-15
Superpotent and Subpotent
- recall — Class II2026-04-15
CGMP Deviations: use of an unapproved raw material
- recall — Class II2026-04-01
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- recall — Class II2026-04-01
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- recall — Class II2026-04-01
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- recall — Class II2026-03-11
Failed Dissolution Specifications
- recall — Class II2026-03-11
Failed Dissolution Specifications
- recall — Class II2026-03-11
Failed Dissolution Specifications
- recall — Class II2026-03-11
Failed Dissolution Specifications
- recall — Class III2025-12-10
Defective Container - A defect in the side-seal which allows leakage of product.
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