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.

151–175 of 196

  • SevereFDA (Drugs)·D-0024-2017·2016-10-19

    Teva Recalls Amikacin Sulfate Injection Due to Manufacturing Deviations

    Teva Pharmaceuticals USA is voluntarily recalling 11,844 vials of Amikacin Sulfate Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    Amikacin Sulfate Injection, USP, 1 gm/4 mL (250 mg/mL) Rx Only, Manufactured in Hungary For: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-9040-01 (individual pack), NDC 0703-9040-03 (shelf-pack carton of 10 vials).
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0095-2017·2016-10-19

    Teva Recalls MitoXANTRONE Injection Due to Potential Impurity D Failure

    Teva Pharmaceuticals USA is recalling MitoXANTRONE Injection USP vials nationwide because they may fail to meet specifications for Impurity D throughout their shelf life.

    Product
    mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0859-2016·2016-06-01

    Teva Recalls Amikacin Sulfate Injection Due to Glass Particulate Matter

    Teva Pharmaceuticals USA is recalling Amikacin Sulfate injection vials because glass particulate matter was identified in one vial.

    Product
    Amikacin Sulfate injection USP,1 gm/4 mL (250 mg/mL) 4mL vial, Rx only, Manufactured in Hungary For: Teva Pharmaceuticals USA, INC. North Wales, PA 19454. Individual Pack NDC 0703-9040-01, Shelf Pack NDC 0703-9040-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0774-2016·2016-03-23

    Teva Recalls Paricalcitol Capsules Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling Paricalcitol Capsules because stability testing revealed out-of-specification impurities. The recall covers 30,891 bottles distributed nationwide and in Puerto Rico.

    Product
    Paricalcitol Capsules, 1 mcg, 30 tablets per Bottle, Rx Only, Manufactured By: Pharmaceutics International, Inc., Hunt Valley, MD 21031, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-7656-56.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0773-2016·2016-03-23

    Teva Recalls Nabumetone Tablets Due to Missing Labels and Leaflets

    Teva Pharmaceuticals USA is recalling 576 bottles of Nabumetone 750 mg tablets because they lack required leaflets and approved labels.

    Product
    NABUMETONE Tablets USP, 750 mg, 100 count bottle,Teva Pharmaceutical Industries Ltd., Jerusalem, 91010, ISRAEL
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0566-2016·2016-01-20

    Teva Recalls Amphetamine Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 9,717 bottles of mixed amphetamine salts tablets because stability testing revealed high impurity levels.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-1351-2015·2015-09-02

    Teva Recalls ADRUCIL Fluorouracil Injection Due to Particulate Matter

    Teva Pharmaceuticals USA is recalling ADRUCIL (fluorouracil injection) vials due to the presence of silicone rubber and fluorouracil crystals in the solution.

    Product
    ADRUCIL (fluorouracil injection, USP), 5 g/100 mL (50 mg/mL) glass vials, 5 x 100 ml vials per carton, manufactured by Teva Parenteral Medicines, Inc., Irvine, CA. NDC 073-3019-11 (individual vial), NDC 0703-3019-12 (carton of five).
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1283-2015·2015-08-12

    Teva Recalls Amphetamine Tablets Due to Unknown Impurity

    Teva Pharmaceuticals is recalling specific lots of amphetamine tablets because they failed impurity specifications. The product contains an unknown impurity.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1089-2015·2015-07-15

    Teva Recalls Adrucil Fluorouracil Injection Due to Particulate Matter

    Teva Pharmaceuticals is recalling Adrucil (fluorouracil injection) vials due to the presence of black particulate matter, including silicone rubber and drug crystals.

    Product
    Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1112-2015·2015-06-10

    Teva Recalls Zebeta Tablets Due to Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling 889 bottles of Zebeta (bisoprolol fumarate) 10mg tablets because they failed dissolution specifications during stability testing.

    Product
    Zebeta¿ (bisoprolol fumarate), tablets, 10mg, 30-count bottle, Rx only, Manufactured for Teva Pharmaceuticals Inc. 425 Privet Road, Horsham, PA by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY 10970 for Teva. NDC 51285-061-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1087-2015·2015-06-03

    Teva Recalls QVAR Inhalers Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling QVAR inhalers because stability testing revealed out-of-specification impurity results.

    Product
    QVAR (beclomethasone dipropionate HFA 40 mcg), 40 mcg Inhalation Aerosol, For Oral Inhalation with QVAR Actuator Only, 120 metered inhalations, Rx Only, Mktd by Teva Respiratory, LLC., Horsham, PA. mfd by 3M Drug Delivery Systems, Northridge, CA, NDC 59310-0202-12
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0971-2015·2015-05-06

    Teva Recalls Fluoxetine Capsules Due to Residual Solvent Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules USP, 20 mg, due to an elevated level of a residual solvent impurity in the active pharmaceutical ingredient.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0970-2015·2015-05-06

    Teva Recalls Fluoxetine Capsules Due to Residual Solvent Impurity

    Teva Pharmaceuticals USA is recalling specific lots of Fluoxetine Capsules 10 mg due to an elevated level of a residual solvent impurity in the active ingredient.

    Product
    FLUOXETINE — FLUOXETINE (FLUOXETINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0050-2015·2014-11-05

    Teva Recalls Dextroamphetamine Tablets Due to Unknown Impurities

    Teva Pharmaceuticals is recalling specific lots of dextroamphetamine tablets because they failed impurity specifications. The recall covers 19,545 bottles distributed nationwide.

    Product
    DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE — DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE (DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1538-2014·2014-08-20

    Teva Recalls Carbidopa and Levodopa Tablets Due to Potential Superpotency

    Teva Pharmaceuticals USA is recalling one lot of Carbidopa and Levodopa Tablets USP, 25mg/100mg, due to the potential for superpotent tablets.

    Product
    Carbidopa and Levodopa Tablets USP, 25mg/100mg, 1000 count bottle, Rx only, Manufactured in Israel by Teva Pharmaceutical IND, LTD., Jeruselem, Israel, for Teva Pharmaceuticals USA, Sellersville, PA, NDC 0093-0293-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1499-2014·2014-08-06

    Teva Recalls Lansoprazole Triple Therapy Blister Packs Due to Impurities

    Teva Pharmaceuticals is recalling 89,215 blister packs of triple therapy containing lansoprazole, clarithromycin, and amoxicillin due to failed impurity specifications.

    Product
    triple therapy, LANSOPRAZOLE DR Capsules USP 30mg, CLARITHROMYCIN Tablets USP 500mg, AMOXICILLIN Capsules USP 500mg, 8 count Blister Pack Lansoprazole DR Capsules USP & Clarithromycin Tablets USP, MANUFACTURED Israel for Teva Pharmaceuticals USA, Sellersville, PA 18960, Amoxici
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1437-2014·2014-07-23

    Teva Recalls Mircette Tablets Due to Out-of-Specification Impurities

    Teva Pharmaceuticals is recalling Mircette tablets because impurity test results were out of specification. The recall covers 984 blister packs distributed nationwide.

    Product
    Mircette (desogestrel/ethinyl estradiol and ethinyl estradiol) Tablets 0.15 mg/0.02 mg and 0.01 mg, 6 Cyclic dispensers X 28 tablets, Rx only Teva Pharmaceuticals, USA, Sellersville, PA. NDC 51285-114-58
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1439-2014·2014-07-23

    Teva Recalls Velivet Birth Control Pills Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 5,265 blister packs of Velivet birth control pills nationwide because impurity test results were out of specification.

    Product
    VELIVET — VELIVET (DESOGESTREL AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1430-2014·2014-07-16

    Teva Recalls Fluvastatin Capsules Due to Reported Capsule Breakage

    Teva Pharmaceuticals is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg, due to a customer complaint trend regarding capsule breakage.

    Product
    FLUVASTATIN — FLUVASTATIN (FLUVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1408-2014·2014-07-02

    Teva Recalls Dextroamphetamine Sulfate Tablets Due to Impurity Test Failures

    Teva Pharmaceuticals is recalling 9,882 bottles of Dextroamphetamine Sulfate 10 mg tablets because stability testing revealed out-of-specification impurities.

    Product
    DEXTROAMPHETAMINE SULFATE — DEXTROAMPHETAMINE SULFATE (DEXTROAMPHETAMINE SULFATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1354-2014·2014-06-04

    Teva Recalls ParaGard T 380A Intrauterine Contraceptives for Sterility Failure

    Teva Pharmaceuticals is recalling 47,890 units of ParaGard T 380A intrauterine contraceptives in New York and Kentucky due to a failed sterility test.

    Product
    ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, Duramed Pharmaceuticals Inc, a subsidiary of Barr Pharmaceuticals, Inc., Pomona, NY
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Drugs)·D-1341-2014·2014-05-28

    Teva Recalls QVAR Inhalation Aerosol Due to Defective Valve

    Teva Pharmaceuticals is recalling QVAR inhalation aerosol canisters because the delivery system and valve are defective.

    Product
    QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1324-2014·2014-05-28

    Teva Recalls Buprenorphine Hydrochloride Sublingual Tablets Due to Impurity Failures

    Teva Pharmaceuticals is recalling 17,181 bottles of 2 mg Buprenorphine Hydrochloride Sublingual Tablets because stability testing revealed high out-of-specification impurity levels.

    Product
    BUPRENORPHINE HYDROCHLORIDE Sublingual Tablets, 2 mg, 30-count bottles, Rx only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0093-5378-56, UPC 3 0093-5378-56 5.
    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.