Home / Brands / Teva Pharmaceuticals USA
Teva Pharmaceuticals USA Recalls
279 recalls on record · June 27, 2012 to May 13, 2026 · Drugs
Recalls by year
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratorie
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratorie
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratori
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laborator
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-05
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 24, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whal
Hazard: Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
October 10, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wale
Hazard: Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
August 15, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High
Hazard: API material used in the manufacturing of the product did not receive regulatory approval prior to release.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Onl
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manu
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Ma
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manuf
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Man
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 1, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufacture
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
July 18, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, I
Hazard: Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
May 30, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-
Hazard: Failed Stability Specifications
March 28, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Estradiol Vaginal Inserts, USP 10 mcg, packaged in a) 8 inserts/carton (NDC 0093-3223-08) and b) 18 inserts/carton (NDC
Hazard: Defective Container: This recall is being initiated due to product complaints regarding difficulty in dispensing the tablet from the applicator.
February 21, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerus
Hazard: Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling all lots within expiry due to out of specification (OOS) test result for the lactoside impurity obtained during routine stability testing activities.
February 14, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavi
Hazard: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
February 14, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis
Hazard: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
February 14, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by:
Hazard: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
February 14, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by:
Hazard: Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
January 17, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By:
Hazard: Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
December 27, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28 tablet dispenser (blister foil unit), Rx o
Hazard: Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
December 20, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufac
Hazard: Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
December 6, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jer
Hazard: Failed Tablet/Capsule Specifications; potential presence of broken tablets.