Skip to main content

Teva Pharmaceuticals USA

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
201812
20196
202022
202153
20227
Download CSV

FDA Recall Terminated Historical recordClass II

Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Published
May 13, 2020
Distribution
Product was distributed to 1 wholesaler…

View recall →

FDA Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM TABLETS, USP 100 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3747-00

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Published
April 15, 2020
Distribution
Bulk product was distributed to one re-p…

View recall →

FDA Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM TABLETS, USP 50 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia, Malta NDC 0591-3746-00

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Published
April 15, 2020
Distribution
Bulk product was distributed to one re-p…

View recall →

FDA Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM TABLETS, USP 25 mg, Bulk, Rx only, For Further Manufacturing, Packing or Repackaging only, Manufactured by: Arrow Pharma (Malta) Ltd., Birzebbugia Malta NDC 0591-3745-00

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Published
April 15, 2020
Distribution
Bulk product was distributed to one re-p…

View recall →

FDA Recall Terminated Historical recordClass II

Mesalamine Delayed-Release Tablets, USP, 1.2 gram, 120-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054; NDC 0591-2245-22.

by Teva Pharmaceuticals USA

Reason
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Published
March 11, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Tramadol Hydrochloride Tablets USP CIV, 50 mg, packaged in a) 100-count bottles (NDC 0093-0058-01), b) 500-count bottles (NDC 0093-0058-05), RX only, Manufactured in Czech Republic for: Teva Pharmaceuticals USA, Inc., North Wales, PA 19545

by Teva Pharmaceuticals USA

Reason
Labeling: Incorrect package insert - Patient leaflets for the specified lots of unscored tablets contain language relative to a 25 mg dosing titration that necessitates the use of a scored 50 mg tablet.
Published
February 26, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01

by Teva Pharmaceuticals USA

Reason
CGMP deviations: Product bottle may be absent of desiccant.
Published
February 19, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01

by Teva Pharmaceuticals USA

Reason
CGMP deviations: Product bottle may be absent of desiccant.
Published
February 19, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01

by Teva Pharmaceuticals USA

Reason
GMP Deviations: Product bottle may be absent of desiccant.
Published
February 12, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass II

Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01

by Teva Pharmaceuticals USA

Reason
GMP Deviations: Product bottle may be absent of desiccant.
Published
February 12, 2020
Distribution
Nationwide

View recall →

FDA Recall Terminated Historical recordClass III

Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 count bottle, Rx only, Manufactured by: Actabis Laboratories FL, Inc., Fort Lauderdale, FL, Distributed by: Actavis Pharma, Inc., Parsippany, NJ NDC 52544-692-30

by Teva Pharmaceuticals USA

Reason
GMP Deviation: lot not intended for commercial distribution.
Published
October 16, 2019
Distribution
Product was distributed to 42 wholesaler…

View recall →

FDA Recall Ongoing Historical recordClass II

LOSARTAN POTASSIUM 100 mg TABLET BULK 90 count bottles, NDC 00591-3747-00

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
Published
July 17, 2019
Distribution
Nationwide

View recall →

This page lists recalls that name Teva Pharmaceuticals USA as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.