The Recall Desk

Manufacturer

Teva Pharmaceuticals USA, Inc.

83 recalls in our database name Teva Pharmaceuticals USA, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
83
Critical
0
Severe
8
Most recent
2026-05-13

Of the 83 recalls from Teva Pharmaceuticals USA, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 8 (10%) 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.

26–50 of 83

  • HighFDA (Drugs)·D-0428-2024·2024-04-03

    Oral Contraceptive Tablets Recalled for Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling TRI-LO-SPRINTEC oral contraceptive tablets nationwide due to failed dissolution specifications affecting 92,676 cartons.

    Product
    TRI-LO-SPRINTEC — TRI-LO-SPRINTEC (NORGESTIMATE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0322-2024·2024-02-21

    Nortrel 7/7/7 Oral Contraceptive Recalled for Discolored Tablets

    Teva Pharmaceuticals is recalling Nortrel 7/7/7 oral contraceptive tablets due to a manufacturing defect: discolored blue tablets mixed with white inert tablets. This could cause confusion about which tablets to take in the triphasic regimen.

    Product
    NORTREL 7/7/7 — NORTREL 7/7/7 (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0321-2024·2024-02-21

    Nortrel Oral Contraceptive Tablets Recalled for Discolored Inert Remainder Tablets

    Teva Pharmaceuticals is recalling 12,916 cartons of Nortrel oral contraceptive tablets nationwide due to discolored inert remainder tablets that may cause confusion. Affected lot: #100042978, expiration 7/31/2024.

    Product
    NORTREL — NORTREL (NORETHINDRONE AND ETHINYL ESTRADIOL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0275-2024·2024-02-07

    FDA Recalls Budesonide Extended-Release Tablets for Failed Dissolution

    FDA has recalled approximately 10,672 bottles of Budesonide Extended-Release Tablets 9mg manufactured by Teva Pharmaceuticals due to failed dissolution specifications.

    Product
    BUDESONIDE — BUDESONIDE (BUDESONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0127-2024·2023-12-06

    Testosterone Gel Recalled for Out-of-Specification Viscosity

    Teva Pharmaceuticals recalls specific lots of Testosterone Gel 1.62% for failing viscosity specifications. Patients should contact their healthcare provider to discuss the recall and obtain unaffected medication.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0913-2023·2023-07-19

    Sunitinib Malate Capsules Recalled Due to Excess Moisture Content

    Teva Pharmaceuticals is recalling 180 bottles of Sunitinib Malate Capsules due to moisture content exceeding approved specifications. The affected lot (100037220) expires 10/2024.

    Product
    SUNITINIB MALATE — SUNITINIB MALATE (SUNITINIB MALATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0768-2023·2023-05-31

    Fentanyl Buccal Tablets 400mcg missing or incorrect package insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 400mcg due to incorrect or missing package inserts in affected cartons distributed nationwide. No illnesses have been reported.

    Product
    Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0767-2023·2023-05-31

    Fentanyl Buccal Tablets Recalled for Missing or Incorrect Package Insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (200mcg) due to missing or incorrect package inserts. Patients should contact their healthcare provider if they have affected product.

    Product
    Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0769-2023·2023-05-31

    Fentanyl Buccal Tablets 600mcg Recalled for Incorrect or Missing Package Insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 600mcg due to incorrect or missing package inserts in 1,908 units distributed nationwide across multiple lot numbers.

    Product
    Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0770-2023·2023-05-31

    Fentanyl buccal tablets recalled due to incorrect or missing package insert

    Teva Pharmaceuticals USA Inc is recalling Fentanyl Buccal Tablets 800mcg due to incorrect or missing package inserts. The recall affects 3,032 units distributed nationwide.

    Product
    Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0766-2023·2023-05-31

    Fentanyl Buccal Tablets recalled due to missing or incorrect package insert

    Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets 100mcg due to incorrect or missing package inserts in affected cartons. Patients should verify proper labeling or contact their pharmacy.

    Product
    Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0510-2023·2023-04-12

    Montelukast Sodium Oral Granules Recalled for Failed Impurity Specifications

    Teva is recalling Montelukast Sodium Oral Granules 4 mg (lot 3007556A) due to failed impurity specifications. The recall affects 3,772 cartons distributed nationwide.

    Product
    Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Carton NDC 0093-7487-56, Packet NDC 0093-7487-19
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0469-2023·2023-03-22

    Eye allergy medication recalled for out-of-specification impurity

    Teva Pharmaceuticals is recalling 715,632 bottles of Clear Eyes Once Daily eye drops due to an out-of-specification impurity found during stability testing.

    Product
    Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL (0.085 fl oz) bottle, Sterile, Distributed by Medtech Products Inc. Tarrytown, NY 10591, A Prestige Consumer Healthcare company, Made in Israel, UPC 67
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0441-2023·2023-03-15

    Metformin Extended-Release Tablets Recalled for Excess NDMA Contamination

    Teva Pharmaceuticals is recalling Metformin hydrochloride Extended-Release Tablets (1000 mg) due to CGMP deviations that resulted in NDMA contamination exceeding the Acceptable Daily Intake Limit. The recall affects 12,044 bottles distributed in California.

    Product
    Metformin hydrochloride Extended-Release Tablets, 1000 mg, 60-count bottle, RX only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 00591-2720-60
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-1539-2022·2022-09-21

    Teva Amphetamine Tablets Recalled Due To Incorrect Strength Labeling

    Teva Pharmaceuticals is recalling 83,703 bottles of prescription amphetamine tablets nationwide because bottles labeled as 15 mg strength actually contain 20 mg tablets, creating risk of unintended overdose. Patients should contact their pharmacy or healthcare provider.

    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
  • HighFDA (Drugs)·D-1302-2022·2022-08-10

    Prescription Drug Matzim LA Extended-Release Tablets Recalled for Failed Dissolution

    Teva Pharmaceuticals is recalling Matzim LA (Diltiazem Hydrochloride) 180 mg tablets because they failed to meet dissolution specifications. The recall affects approximately 8,022 bottles distributed nationwide in the United States and Puerto Rico.

    Product
    MATZIM LA — MATZIM LA (DILTIAZEM HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1303-2022·2022-08-10

    Matzim LA Extended-Release Tablets Recalled for Dissolution Specification Failure

    Matzim LA Extended-Release Tablets, 240 mg are being recalled due to failed dissolution specifications. Patients taking this medication should consult their doctor about their treatment.

    Product
    Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1289-2022·2022-08-03

    Prescription testosterone gel recalled due to out-of-specification potency

    Teva Pharmaceuticals is recalling testosterone gel lot 1403180 after stability testing revealed out-of-specification assay results indicating superpotency. The affected 12,354 cartons were distributed nationwide.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1156-2022·2022-06-29

    Tretinoin Capsules Recalled Nationwide for Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling Tretinoin Capsules (10 mg) nationwide due to failed dissolution specifications that may affect medication effectiveness. Patients should contact their pharmacist or doctor to confirm if their prescription is affected.

    Product
    Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0988-2022·2022-06-15

    FDA Recalls Teva Alprostadil Injection for Failed Impurity Specifications

    Teva Pharmaceuticals USA Inc is recalling Alprostadil Injection USP due to out-of-specification results for impurities identified during routine stability testing. This FDA Class III recall affects 3,109 cartons distributed nationwide.

    Product
    Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Carton, Rx Only, Carton NDC 0703-1501-02, Distributed by: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, Vial NDC 0703-1501-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0992-2022·2022-06-08

    Anagrelide Capsules Recalled Due to Failed Dissolution Specifications

    Teva Pharmaceuticals is recalling Anagrelide Capsules USP 0.5 mg nationwide due to failed dissolution specifications discovered during stability testing. The recall involves lot GD01090 (expired May 2022).

    Product
    Anagrelide Capsules USP, 0.5 mg, 100-count bottles, Rx Only, Manufactured in India For: TEVA PHARMACEUTICALS USA, Inc., North Wales, PA 19454. NDC 0172-5241-60.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0794-2022·2022-05-04

    FDA Recalls Lidocaine-Prilocaine Topical Cream for Manufacturing Practice Violations

    Teva Pharmaceuticals initiated a voluntary recall of Lidocaine-Prilocaine Cream due to manufacturing practice violations. The recall affects 353,964 units distributed nationwide.

    Product
    Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0765-2022·2022-04-20

    FDA Recalls IDArubicin Injection for Particulate Matter Contamination

    Teva Pharmaceuticals is recalling IDArubicin Hydrochloride Injection vials due to the presence of silica and iron oxide particulate matter. The recall affects nationwide distribution within the United States.

    Product
    IDArubicin Hydrochloride Injection USP 5gm/5mL (1mg/mL) for intravenous use, 5mL Single Dose Vial, Rx Only, Teva Pharmaceuticals, USA, Inc., North Wales, PA 19454, NDC 0703-4154-11.
    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.