Teva Pharmaceuticals USA, Inc

FDA Regulatory Profile

Summary

Total Recalls
277 (6 Class I)
510(k) Clearances
0
Inspections
16
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0474-2026Class IIClonidine Transdermal System, USP, 0.3 mg/day, supplied in cartons of 4 Systems and 4 Adhesive CoverMarch 19, 2026
D-0472-2026Class IIClonidine Transdermal System, USP, 0.1 mg/day, supplied in cartons of 4 Systems and 4 Adhesive CoverMarch 19, 2026
D-0473-2026Class IIClonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive CoverMarch 19, 2026
D-0405-2026Class IIOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 20 mg, Single-dose 8 mLMarch 17, 2026
D-0404-2026Class IIOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mLMarch 17, 2026
D-0406-2026Class IIOctreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mLMarch 17, 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-0356-2026Class IIMetoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-January 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-0445-2026Class IIIsotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva PharmJanuary 12, 2026
D-0446-2026Class IIIsotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva PharmJanuary 12, 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-0105-2026Class IIPrazosin Hydrochloride, Capsules, USP, 2 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-0106-2026Class IIPrazosin Hydrochloride, Capsules, USP, 5 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