Teva Pharmaceuticals USA recalls

164 recalls on record · latest: January 18, 2022

Official U.S. recall history for Teva Pharmaceuticals USA, compiled from official government records.

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Teva Pharmaceuticals USA recalls Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manuf…

January 18, 2022 · Drug & medication recalls Moderate risk Failed Dissolution Specification: Dissolution results are below specification l…

Teva Pharmaceuticals USA recalls Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0…

January 10, 2022 · Drug & medication recalls Moderate risk Failed Dissolution Specifications; Low Out of specification (OOS) results for d…

Mimvey 1 mg/0 recalled over labeling errors

January 7, 2022 · Drug & medication recalls Mislabeling

Mimvey recalled over labeling errors

January 7, 2022 · Drug & medication recalls Mislabeling

MethylPREDNISolone Acetate Injectable Suspension USP 400 mg/ recalled over sterility concerns

December 31, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Norepinephrine Bitartrate Injection USP 4 mg/ recalled over sterility concerns

December 31, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Teva Pharmaceuticals USA recalls Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml droppe…

December 8, 2021 · Drug & medication recalls Moderate risk Defective Container: The notch in the cap that fits into the nozzle of the drop…

Teva Pharmaceuticals USA recalls AirDuo Digihaler 55/14 (fluticasone propionate 55 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Teva…

September 22, 2021 · Drug & medication recalls Moderate risk Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA recalls AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale,…

September 22, 2021 · Drug & medication recalls Moderate risk Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA recalls AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd. by: Te…

September 22, 2021 · Drug & medication recalls Moderate risk Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA recalls AirDuo Digihaler 232/14 (fluticasone propionate 232 mcg and salmeterol 14 mcg) Inhalation Powder, Rx Only, Mktd by: Tev…

September 22, 2021 · Drug & medication recalls Moderate risk Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Teva Pharmaceuticals USA recalls AirDuo Digihaler 113/14 (fluticasone propionate 113 mcg and salmeterol 14 mcg) Inhalation Powder, Sample Not For Sale,…

September 22, 2021 · Drug & medication recalls Moderate risk Subpotent drug: OOS results of Label Claimed Emitted Dose for salmeterol

Epoprostenol Sodium for Injection recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

DAUNOrubicin Hydrochloride Injection 20 mg/ recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Leucovorin Calcium for Injection recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Methylprednisolone Acetate Injectable Suspension USP recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Norepinephrine Bitartrate Injection recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Octreotide Acetate Injection 1000 mcg/ recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Methylprednisolone Acetate Injectable Suspension USP recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Idarubicin Hydrochloride Injection 20 mg/ recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Leucovorin Calcium for Injection recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Octreotide Acetate Injection 100 mcg/mL recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Octreotide Acetate Injection 50 mcg/mL recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Haloperidol Decanoate Injection 100 mg/mL recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Leucovorin Calcium for Injection recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Adenosine Injection recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Amikacin Sulfate Injection USP / recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Alprostadil Injection USP recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Metoclopramide Injection USP recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Vecuronium Bromide for Injection 10 mg recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Adenosine Injection recalled over sterility concerns

July 29, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Cyclobenzaprine Hydrochloride Tablets recalled over manufacturing violations

July 29, 2021 · Drug & medication recalls Moderate risk CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Micro…

Cyclobenzaprine Hydrochloride Tablets recalled over manufacturing violations

July 29, 2021 · Drug & medication recalls Moderate risk CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Micro…

Cyclobenzaprine Hydrochloride Tablets recalled over manufacturing violations

July 29, 2021 · Drug & medication recalls Moderate risk CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Micro…

Teva Pharmaceuticals USA recalls Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceuticals USA, Inc. North Whales, PA 19454, Carton…

June 18, 2021 · Drug & medication recalls High risk Presence of Particulate Matter: Complaint received of a glass particle observed…

Haloperidol Decanoate Injection recalled over sterility concerns

April 26, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Leucovorin Calcium for Injection recalled over sterility concerns

April 26, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Metoclopramide Injection USP recalled over sterility concerns

April 26, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Haloperidol Decanoate Injection recalled over sterility concerns

April 26, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Methylprednisolone Acetate Injectable Suspension USP recalled over sterility concerns

April 26, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Teva Pharmaceuticals USA recalls Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

March 4, 2021 · Drug & medication recalls Failed Impurity/Degradation Specifications: Out-of-specifications results obser…

Teva Pharmaceuticals USA recalls Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials, Rx only, Distributed by Teva Pharmaceutic…

February 15, 2021 · Drug & medication recalls Moderate risk Chemical contamination; Unknown brown residue adhering to the inside of one via…

Epoprostenol Sodium for Injection recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Metoclopramide Injection USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Sterile Diluent for Epoprostenol Sodium for Injection recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Desmopressin Acetate Injection USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Dacarbazine for Injection USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Vecuronium Bromide for Injection recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

MethyIPREDNISolone Acetate Injectable Suspension USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

MethyIPREDNISolone Acetate Injectable Suspension USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Toposar recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Epoprostenol Sodium for Injection recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

MethyIPREDNISolone Acetate Injectable Suspension USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

MethyIPREDNISolone Acetate Injectable Suspension USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Leucovorin Calcium for Injection recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Leucovorin Calcium for Injection recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

MethyIPREDNISolone Acetate Injectable Suspension USP recalled over sterility concerns

February 10, 2021 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility: manufacturing areas for the recalled products e…

Teva Pharmaceuticals USA recalls Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose P…

November 11, 2020 · Drug & medication recalls Superpotent Drug: High out-of-specification assay results were obtained during…

Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP 1.2 gram, 120 tablets per bottle, Rx Only, Manufactured by: Actavis Laboratorie…

October 28, 2020 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: Out-of-specification dissolution results wer…

Teva Pharmaceuticals USA recalls Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured b…

September 4, 2020 · Drug & medication recalls Moderate risk Failed Stability Specifications: Below specification result for buprenorphine r…

Cephalexin for Oral Suspension recalled over manufacturing violations

August 24, 2020 · Drug & medication recalls Moderate risk CGMP deviations; there is a possibility that some bottles in these lots may hav…

Cephalexin for Oral Suspension recalled over manufacturing violations

August 24, 2020 · Drug & medication recalls Moderate risk CGMP deviations; there is a possibility that some bottles in these lots may hav…

Teva Pharmaceuticals USA recalls Cephalexin for Oral Suspension, USP 250 mg per 5 mL, For Reconstitution, For Oral Use Only, Rx Only, 100 mL bottle when…

August 24, 2020 · Drug & medication recalls Moderate risk Sub-Potent Drug: Out of specification test results for potency (below specifica…

Teva Pharmaceuticals USA recalls Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake Ci…

July 14, 2020 · Drug & medication recalls Moderate risk Labeling: Incorrect or Missing Lot and/or Exp date on the individual transderma…

Metformin Hydrochloride Extended - Release Tablets recalled over manufacturing violations

June 2, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity a…

Metformin Hydrochloride Extended-Release Tablets recalled over manufacturing violations

June 2, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity a…

Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed…

May 22, 2020 · Drug & medication recalls Moderate risk Some bottles may contain mixed strengths of the product.

Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed…

May 22, 2020 · Drug & medication recalls Moderate risk Some bottles may contain mixed strengths of the product.

Teva Pharmaceuticals USA recalls Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets ( Mixed…

May 22, 2020 · Drug & medication recalls Moderate risk Some bottles may contain mixed strengths of the product.

LOSARTAN POTASSIUM TABLETS recalled over manufacturing violations

March 25, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) det…

LOSARTAN POTASSIUM TABLETS recalled over manufacturing violations

March 25, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) det…

LOSARTAN POTASSIUM TABLETS recalled over manufacturing violations

March 25, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) det…

Teva Pharmaceuticals USA recalls Actavis — Valsartan and Valsartan Hydrochlorothiazide Tablets

March 24, 2020 · Drug & medication recalls Impurity — Potential Lack of Sterility

Epinephrine Injection USP recalled over manufacturing violations

March 5, 2020 · Drug & medication recalls Moderate risk CGMP Deviations: Precautions taken due to Out-of-specification for trigger forc…

Teva Pharmaceuticals USA recalls Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL,…

February 20, 2020 · Drug & medication recalls Moderate risk Failed Dissolution Specifications: Low out of specification dissolution result…

Teva Pharmaceuticals USA recalls Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottle…

January 28, 2020 · Drug & medication recalls Labeling: Incorrect package insert - Patient leaflets for the specified lots of…

Teva Pharmaceuticals USA recalls Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Laude…

January 27, 2020 · Drug & medication recalls Moderate risk GMP Deviations: Product bottle may be absent of desiccant.

Teva Pharmaceuticals USA recalls Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Laude…

January 27, 2020 · Drug & medication recalls Moderate risk GMP Deviations: Product bottle may be absent of desiccant.

Methylphenidate hydrochloride Extended-Release ablets USP recalled over manufacturing violations

January 27, 2020 · Drug & medication recalls Moderate risk CGMP deviations: Product bottle may be absent of desiccant.

Methylphenidate hydrochloride Extended-Release ablets USP recalled over manufacturing violations

January 27, 2020 · Drug & medication recalls Moderate risk CGMP deviations: Product bottle may be absent of desiccant.

Teva Pharmaceuticals USA recalls Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabi…

September 6, 2019 · Drug & medication recalls GMP Deviation: lot not intended for commercial distribution.

LOSARTAN POTASSIUM 50 mg TABLET BULK bottles and bottles recalled over manufacturing violations

June 6, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) det…

LOSARTAN POTASSIUM 100 mg TABLET BULK bottles recalled over manufacturing violations

June 6, 2019 · Drug & medication recalls Moderate risk CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) det…

Teva Pharmaceuticals USA recalls Amoxicillin for Oral Suspension USP, 125 mg per 5 mL, packaged in (a) 150 mL bottle (NDC 0093-4150-80) (b) 80 mL bottle…

April 12, 2019 · Drug & medication recalls Moderate risk Subpotent Product: assay results for Amoxicillin were below the specification l…

Amlodipine and Valsartan Tablets 5 mg/160 mg recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Amlodipine and Valsartan Tablets 5 mg/320 mg recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Amlodipine and Valsartan Tablets 10 mg/320 mg bottles & bottles recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Amlodipine recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Amlodipine and Valsartan Tablets 10 mg/160 mg recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Amlodipine recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Amlodipine recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Amlodipine recalled over manufacturing violations

November 27, 2018 · Drug & medication recalls Moderate risk CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-ni…

Teva Pharmaceuticals USA recalls Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laborator…

October 19, 2018 · Drug & medication recalls Moderate risk Failed dissolution specifications: Out-of-Specification dissolution test result…

Teva Pharmaceuticals USA recalls Alprostadil Injection USP 500 micrograms/mL 1 mL single use vial, 5 vials per carton, Rx only, TEVA Pharmaceuticals USA…

September 27, 2018 · Drug & medication recalls Moderate risk Failed Impurities/Degradation Specifications; out-of-specification results for…

Teva Pharmaceuticals USA recalls Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wal…

September 21, 2018 · Drug & medication recalls Moderate risk Failed Disintegration Specifications: Out-of-specification disintegration test…