Teva Pharmaceuticals USA
Teva Pharmaceuticals USA has 281 FDA recalls (6 Class I), 17 inspections, 0 510(k) clearances and 0 compliance actions on record.
- Latest recall
- D-0038-2027 · Class II · Sep 29, 2026
- Latest inspection
- Jul 20, 2026 · VAI
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 281 (6 Class I) | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 17 | Nov 8, 2026 | Newest record Oct 28, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Related names
| Name | Recalls | 510(k) | Inspections | Compliance | Most recent recall |
|---|---|---|---|---|---|
| Actavis Pharma | 1 | 0 | 0 | 0 | Mar 16, 2016 (D-1060-2016) |
| Teva Pharmaceutical Industries | 1 | 0 | 18 | 1 | Oct 20, 2015 (D-0521-2016) |
| Watson Laboratories | 22 | 0 | 10 | 0 | Jan 15, 2014 (D-1053-2014) |
| Teva Canada Limited | 0 | 0 | 19 | 0 | — |
| Teva Branded Pharmaceutical Products R And D | 0 | 0 | 14 | 0 | — |
| Barr Laboratories | 0 | 0 | 13 | 0 | — |
| Teva Parenteral Medicines | 0 | 0 | 11 | 1 | — |
| Teva Womens Health | 0 | 0 | 12 | 0 | — |
| Teva Puerto Rico | 0 | 0 | 8 | 1 | — |
| Pliva Hrvatska | 0 | 0 | 8 | 0 | — |
| Teva Czech Industries S.R.O | 0 | 0 | 8 | 0 | — |
| Teva Api India Private | 0 | 0 | 5 | 0 | — |
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| D-0038-2027 | Class II | Metoclopramide Tablets, USP, 5 mg, [100 or 500] Tablets per bottle, Rx Only, Manufactured for: Teva… | Sep 29, 2026 |
| D-0834-2026 | Class II | traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva… | Aug 24, 2026 |
| D-0519-2026 | Class II | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose… | Apr 24, 2026 |
| D-0521-2026 | Class II | Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with… | Apr 6, 2026 |
| D-0474-2026 | Class II | Clonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive… | Mar 19, 2026 |
| D-0472-2026 | Class II | Clonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive… | Mar 19, 2026 |
| D-0473-2026 | Class II | Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive… | Mar 19, 2026 |
| D-0406-2026 | Class II | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL… | Mar 17, 2026 |
| D-0404-2026 | Class II | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL… | Mar 17, 2026 |
| D-0405-2026 | Class II | Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mL… | Mar 17, 2026 |
| D-0355-2026 | Class II | Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and… | Jan 29, 2026 |
| D-0354-2026 | Class II | Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and… | Jan 29, 2026 |
| D-0356-2026 | Class II | Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC… | Jan 29, 2026 |
| D-0357-2026 | Class II | Metoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva… | Jan 29, 2026 |
| D-0445-2026 | Class II | Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva… | Jan 12, 2026 |
| D-0446-2026 | Class II | Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva… | Jan 12, 2026 |
| D-0198-2026 | Class III | Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only… | Nov 7, 2025 |
| D-0151-2026 | Class II | Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when… | Oct 13, 2025 |
| D-0104-2026 | Class II | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC… | Oct 7, 2025 |
| D-0106-2026 | Class II | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC… | Oct 7, 2025 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Jul 20, 2026 | Fairfield, NJ | Drugs | Voluntary Action Indicated (VAI) | 2245641 |
| Sep 9, 2025 | Parsippany, NJ | Drugs | No Action Indicated (NAI) | 3003092769 |
| Sep 29, 2023 | Parsippany, NJ | Drugs | Voluntary Action Indicated (VAI) | 3003092769 |
| Nov 10, 2022 | Fairfield, NJ | Drugs | Voluntary Action Indicated (VAI) | 2245641 |
| Dec 16, 2021 | Parsippany, NJ | Drugs | No Action Indicated (NAI) | 3003092769 |
| Jan 11, 2018 | Fairfield, NJ | Drugs | No Action Indicated (NAI) | 2245641 |
| Dec 14, 2017 | Malvern, PA | Drugs | No Action Indicated (NAI) | 3010852760 |
| Feb 1, 2017 | Fairfield, NJ | Drugs | Voluntary Action Indicated (VAI) | 2245641 |
| Mar 5, 2015 | Mexico, MO | Drugs | No Action Indicated (NAI) | 1938125 |
| Nov 6, 2013 | Fairfield, NJ | Drugs | No Action Indicated (NAI) | 2245641 |
| Mar 30, 2012 | Fairfield, NJ | Drugs | No Action Indicated (NAI) | 2245641 |
| Feb 9, 2012 | Mexico, MO | Drugs | Voluntary Action Indicated (VAI) | 1938125 |
| Dec 2, 2010 | Parsippany, NJ | Drugs | Voluntary Action Indicated (VAI) | 3003092769 |
| Mar 19, 2010 | Fairfield, NJ | Drugs | No Action Indicated (NAI) | 2245641 |
| Mar 1, 2010 | Parsippany, NJ | Drugs | Voluntary Action Indicated (VAI) | 3003092769 |
| Aug 14, 2009 | Parsippany, NJ | Drugs | Voluntary Action Indicated (VAI) | 3003092769 |
| Dec 12, 2008 | Mexico, MO | Drugs | No Action Indicated (NAI) | 1938125 |
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 2245641 | Fairfield, NJ | 7 | Jul 20, 2026 |
| FEI 3003092769 | Parsippany, NJ | 6 | Sep 9, 2025 |
| FEI 3010852760 | Malvern, PA | 1 | Dec 14, 2017 |
| FEI 1938125 | Mexico, MO | 3 | Mar 5, 2015 |