Teva Pharmaceuticals USA, Inc.

FDA Regulatory Profile

Summary

Total Recalls
269 (6 Class I)
510(k) Clearances
0
Inspections
16
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0356-2026Class IIMetoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-January 29, 2026
D-0355-2026Class IIMetoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,January 29, 2026
D-0357-2026Class IIMetoprolol Succinate Extended-Release Tablets, 200 mg, 100 tablets bottles, Rx Only, Teva PharmaceutJanuary 29, 2026
D-0354-2026Class IIMetoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,January 29, 2026
D-0198-2026Class IIICarton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, ManNovember 7, 2025
D-0151-2026Class IIAmoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg per 5mL, 100 mL (when October 13, 2025
D-0106-2026Class IIPrazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC.,October 7, 2025
D-0104-2026Class IIPrazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC.,October 7, 2025
D-0105-2026Class IIPrazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC.,October 7, 2025
D-0473-2025Class IIMetoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in Croatia by Pliva HrvatMay 23, 2025
D-0218-2025Class IIGranix (tbo-filgrastim) Injection 300 mcg/0.5 mL, Single Dose prefilled syringe, packaged as a) 1 syJanuary 10, 2025
D-0637-2024Class IITestosterone Gel, 1.62%, (Alcohol 80% v/v), 30 unit-dose packets, Rx Only, Teva Pharmaceuticals, USAAugust 8, 2024
D-0601-2024Class IIFludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle, Manufactured in Canada June 28, 2024
D-0561-2024Class IIAmoxicillin and Clavulanate Potassium Tablets USP, Chewable 400mg/57mg, 20-count bottles, Rx only, MJune 4, 2024
D-0439-2024Class IIIsotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For:March 28, 2024
D-0428-2024Class IITri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in caMarch 7, 2024
D-0322-2024Class IIINortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartJanuary 25, 2024
D-0321-2024Class IIINortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton cJanuary 25, 2024
D-0275-2024Class IIBudesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis LaboratJanuary 8, 2024
D-0127-2024Class IIITestosterone Gel, 1.62% CIII (Alcohol 80% v/v), packaged in 30 unit-dose packets per carton, Rx onlyNovember 10, 2023