The Recall Desk

Manufacturer

Teva Pharmaceuticals USA

196 recalls in our database name Teva Pharmaceuticals USA as the manufacturing or recalling firm.

What the numbers show

Total
196
Critical
1
Severe
86
Most recent
2022-02-09

Of the 196 recalls from Teva Pharmaceuticals USA we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 86 (44%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

101–125 of 196

  • HighFDA (Drugs)·D-0102-2019·2018-10-31

    Teva Recalls Pioglitazone and Metformin Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Pioglitazone and Metformin tablets because some may lack laser drilling, potentially affecting drug release.

    Product
    PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkwa
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0101-2019·2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling specific lots of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0100-2019·2018-10-31

    Teva Recalls Metformin Hydrochloride Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals USA is recalling 82,291 bottles of Metformin Hydrochloride Extended Release Tablets 1000 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0129-2019·2018-10-31

    Teva Recalls Metoprolol Succinate Extended Release Tablets Due to Dissolution Failure

    Teva Pharmaceuticals USA is recalling 53,451 bottles of Metoprolol Succinate Extended Release Tablets 50 mg because routine stability testing revealed out-of-specification dissolution results.

    Product
    Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0096-2019·2018-10-31

    Teva Recalls Paliperidone Extended Release Tablets Due to Defective Delivery System

    Teva Pharmaceuticals is recalling 27,816 bottles of Paliperidone Extended Release Tablets 3 mg because some tablets may be missing laser drilling, which could affect drug release.

    Product
    Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0082-2019·2018-10-24

    Teva Recalls Clonazepam Tablets Due to Failed Stability Specifications

    Teva Pharmaceuticals is recalling 1,373 cartons of Clonazepam Orally Disintegrating Tablets because routine stability testing revealed out-of-specification water content.

    Product
    Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whales, PA 19454. NDC 0555-0098-96
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0001-2019·2018-10-10

    Teva Recalls Clozapine Tablets Due to Failed Disintegration Testing

    Teva Pharmaceuticals is recalling 313 bottles of Clozapine 12.5 mg tablets because routine stability testing showed the tablets failed to disintegrate as required.

    Product
    CLOZAPINE — CLOZAPINE (CLOZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1074-2018·2018-08-15

    Teva Recalls Omega-3 Capsules Due to Unapproved Manufacturing Material

    Teva Pharmaceuticals is recalling 13,715 bottles of Omega-3-Acid Ethyl Esters Capsules because an API material used in manufacturing did not receive regulatory approval prior to release.

    Product
    Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0985-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/25 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0984-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 mg/12.5 mg tablets, USP, 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2318-19
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0981-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 80 mg/12.5 mg tablets, 90 count-count bottle, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, NDC 0591-2315-19.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0982-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0987-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 80 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 80 mg, 90-count bottle (NDC 0591-2168-19), 1000-count bottle (NDC 0591-2168-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0989-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 320 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0983-2018·2018-08-01

    Teva Recalls Valsartan and Hydrochlorothiazide Tablets Due to Carcinogen Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan and Hydrochlorothiazide tablets because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/25 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2317-19.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0988-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 160 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0986-2018·2018-08-01

    Teva Recalls Valsartan Tablets Due to Carcinogen Impurity in API

    Teva Pharmaceuticals USA is recalling specific lots of Valsartan Tablets 40 mg because a carcinogen impurity was detected in the active pharmaceutical ingredient.

    Product
    Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0857-2018·2018-05-30

    Teva Recalls Lidocaine Patches Due to Failed Stability Specifications

    Teva Pharmaceuticals USA is recalling Lidocaine Patch 5% products because they failed stability specifications. The recall covers 30,382 patches distributed in the United States.

    Product
    LIDOCAINE — LIDOCAINE (LIDOCAINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0578-2018·2018-02-21

    Teva Recalls Fluoxetine Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals USA is voluntarily recalling Fluoxetine Tablets USP, 10 mg, because routine stability testing revealed an out-of-specification lactoside impurity.

    Product
    Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Israel by: Teva Pharmaceuticals IND, LTD, Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, INC., North Wales, PA 19454, NDC 0093-7188-56
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0542-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Levels

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because they contain a degradant called Fentanyl-n-Oxide that exceeds safety limits.

    Product
    Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0540-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems 25 mcg/h because a degradation product exceeded specification limits.

    Product
    Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0541-2018·2018-02-14

    Teva Recalls Fentanyl Patches Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3212-54.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0543-2018·2018-02-14

    Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits

    Teva Pharmaceuticals is recalling specific lots of Fentanyl Transdermal Systems because a degradation product exceeded safety limits.

    Product
    Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54.
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Teva Pharmaceuticals CR

company in Prague, Czechia

Country
Czech Republic
Founded
1997

Official website

Source: Wikidata (Q41567143), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.