The Recall Desk

Manufacturer

Teva North America

12 recalls in our database name Teva North America as the manufacturing or recalling firm.

What the numbers show

Total
12
Critical
0
Severe
3
Most recent
2016-10-12

Of the 12 recalls from Teva North America we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 3 (25%) 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.

1–12 of 12

  • ModerateFDA (Drugs)·D-0005-2017·2016-10-12

    Teva Recalls Claravis Isotretinoin Capsules Due to Impurity Failures

    Teva North America is recalling Claravis (isotretinoin) capsules because they failed impurity and degradation specifications.

    Product
    Claravis (isotretinoin capsules USP), 10mg, packaged in carton containing 3 Blister Packs of 10 Capsules Each (30 Capsules total); Rx only, TEVA PHARMACEUTICALS USA, Sellersville, PA 18960. NDC 00555-1054-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1495-2016·2016-09-14

    Teva Recalls Linezolid Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 92,480 containers of Linezolid Injection 600 mg/300 mL due to CGMP deviations. The recall covers products distributed nationwide and in Puerto Rico.

    Product
    Linezolid Injection 600 mg/300 mL Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-9060-31- (Single Use Container), NDC# 0703-9060-33 (Box of 10 Singe Use Containers)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1496-2016·2016-09-14

    Teva Recalls Eptifibatide Injection Vials Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 14,661 vials of Eptifibatide Injection due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-1179-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1497-2016·2016-09-14

    Teva Recalls Ondansetron Injection Vials Due to Manufacturing Deviations

    Teva North America is recalling 13,223 vials of Ondansetron Injection USP due to CGMP deviations. The recall covers lots distributed nationwide and in Puerto Rico.

    Product
    Ondansetron Injection USP 40 mg/20 mL (2 mg/mL), Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454 NDC # 0703-7226-01 (20 mL- Multi-dose Vial), NDC # 0703-72263-03 (10 Multi-dose Vials per carton)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1494-2016·2016-09-14

    Teva Recalls Argatroban Injection Due to Manufacturing Deviations

    Teva North America is voluntarily recalling 1,299 bags of Argatroban Injection due to Current Good Manufacturing Practice (CGMP) deviations.

    Product
    ARGATROBAN Injection in 0.9% Sodium Chloride 250 mg/250 mL (1 mg/mL) , Rx Only, Manufactured in Hungary for TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC# 0703-0020-31 (Single Use Bag), NDC # 0703-0020-32 (5 Single Use Bags in One Carton).
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1470-2016·2016-08-31

    Teva Recalls Amoxicillin Oral Suspension Due to Potency Issues

    Teva North America is recalling Amoxicillin for Oral Suspension because stability testing showed the drug was superpotent.

    Product
    AMOXICILLIN — AMOXICILLIN (AMOXICILLIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1455-2016·2016-08-17

    Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles

    Teva North America is recalling 8,052 bottles of Albuterol Sulfate Syrup because black particles were found in the product.

    Product
    Albuterol Sulfate Syrup, 2 mg/ 5 mL, 473 mL bottle, Rx only, Manufactured in Canada by Contract Pharmaceuticals Limited, Canada, Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA --- NDC 0093-0661-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1453-2016·2016-08-10

    Teva Recalls Children's Qnasl Nasal Aerosol for Content Uniformity Failure

    Teva North America is recalling Children's Qnasl nasal aerosol canisters due to failed spray content uniformity tests. The FDA classified this as a Class III recall.

    Product
    Children's Qnasl 40 mcg (beclomethasone dipropionate) Nasal Aerosol, 40 mcg per spray, 60 Metered Sprays per canister, 4.9g Net Contents, Rx only; Professional Sample; Manufactured for Teva Respiratory, LLC, Horsham, PA 19044; By: 3M Drug Delivery Systems, Northridge, CA 91324;
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1449-2016·2016-08-03

    Teva Recalls Divalproex Sodium Tablets Due to Failed Specifications

    Teva North America is recalling Divalproex Sodium Delayed-release Tablets because they failed tablet specifications. The recall covers 14,370 units distributed nationwide and in Puerto Rico.

    Product
    Divalproex Sodium Delayed-release Tablets USP, RX, 250 mg, 100 count bottles, Manufactured in Israel by: TEVA PHARMACEUTICALS IND. LTD. Jerusalem, 9777402, Israel, Manufactured for: TEVA PHARMACEUTICALS USA, INC. North Wales, PA 19454, NDC 0093-7440-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1451-2016·2016-08-03

    Teva Recalls MitoXANTRONE Injection Due to High Impurity Levels

    Teva North America is recalling 2,506 vials of MitoXANTRONE Injection USP because high levels of Impurity D were detected.

    Product
    mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0868-2016·2016-06-01

    Teva Recalls Linezolid Injection Bags Due to Sterility Concerns

    Teva North America is recalling 546 bags of Linezolid Injection due to potential leaking that compromises sterility.

    Product
    Linezolid Injection, 600 mg/300 mL Single use container bags (NDC 0703-9060-31), packaged in 10 x 300 mL Single Use Container bags per Box Pack (NDC 0703-9060-33), Rx only, Manufactured In Hungary By: Teva Pharmaceutical Works Ltd., Hungary, H-2100 Godollo, Tancsics M. ut 82 Hung
    Category
    Drug
    Distribution
    Distributed nationwide