The Recall Desk

Manufacturer

Sandoz Incorporated

16 recalls in our database name Sandoz Incorporated as the manufacturing or recalling firm.

What the numbers show

Total
16
Critical
0
Severe
5
Most recent
2018-04-25

Of the 16 recalls from Sandoz Incorporated we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (31%) 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.

1–16 of 16

  • ModerateFDA (Drugs)·D-0631-2018·2018-04-25

    Sandoz Recalls Triamterene and Hydrochlorothiazide Tablets Due to Cross-Contamination

    Sandoz Incorporated is recalling specific lots of Triamterene and Hydrochlorothiazide Tablets due to the presence of unrelated ingredients.

    Product
    Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0943-2017·2017-07-12

    Sandoz Recalls Amitriptyline Hydrochloride Tablets Due to Cross-Contamination

    Sandoz Incorporated is recalling specific lots of Amitriptyline Hydrochloride 25 mg tablets because they were cross-contaminated with Imipramine.

    Product
    AMITRIPTYLINE HYDROCHLORIDE — AMITRIPTYLINE HYDROCHLORIDE (AMITRIPTYLINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0236-2017·2017-01-04

    Sandoz Recalls Nadolol Tablets Due to Failed Dissolution Test

    Sandoz Incorporated is recalling 96 bottles of Nadolol Tablets, 40mg, because the product failed a required dissolution test.

    Product
    Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0781-1182-10
    Category
    Drug
    Distribution
    2 states
  • LowFDA (Drugs)·D-0291-2015·2014-12-17

    Sandoz Recalls Fluoxetine Capsules Due to Illegible Logo

    Sandoz Inc. is recalling one lot of Fluoxetine Capsules because the logo on the capsules is illegible.

    Product
    Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1509-2014·2014-08-06

    Sandoz Recalls Alprazolam Tablets Due to Stainless Steel Particulates

    Sandoz Incorporated is recalling 1,332 bottles of Alprazolam 0.25mg tablets nationwide because they may contain stainless steel metal particulates.

    Product
    ALPRAZOLAM — ALPRAZOLAM (ALPRAZOLAM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-66373-001·2013-10-16

    Sandoz Recalls Hydroxychloroquine Tablets Due to Illegible Logo

    Sandoz is recalling one lot of Hydroxychloroquine Sulfate Tablets because the logo on some tablets is illegible.

    Product
    Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC 0781-1407-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-832-2013·2013-08-14

    Sandoz Recalls Methotrexate Injection Vials Due to Particulate Matter

    Sandoz Incorporated is recalling specific lots of Methotrexate Injection vials because particulate matter was found in retention samples.

    Product
    Methotrexate Injection, USP, Preservative-Free, 1 g/40 mL (25 mg/mL), 40 mL Single Dose Vial, Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540; Manufactured by: EBEWE Pharma Ges.m.b.H. Nfg.KG, A-4866 Unterach, AUSTRIA, NDC 66758-041-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-854-2013·2013-08-14

    Sandoz Recalls Introvale Contraceptive Tablets Due to Sequence Error

    Sandoz is voluntarily recalling Introvale contraceptive tablets because inactive and active pills were placed in the wrong weeks on the blister card.

    Product
    Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit carton, 3 Unit Cartons x 91 tablets per box, Rx only, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5584-36
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-805-2013·2013-07-24

    Sandoz Recalls Estarylla Contraceptive Tablets Due to Placebo Tablet Error

    Sandoz Incorporated is recalling Estarylla tablets because a placebo tablet was found in a row of active tablets, which could reduce contraceptive effectiveness.

    Product
    Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactured by Laboratorios Leon Farma S.A. Spain for Sandoz Inc. Princeton, NJ 08540, NDC 0781-4058-15
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-597-2013·2013-06-19

    Sandoz Recalls Cefazolin Injection Vials Due to Sterility Concerns

    Sandoz Inc. is recalling Cefazolin for Injection, USP 1 gm vials, lot DB2208, due to a lack of assurance of sterility caused by broken or cracked vials.

    Product
    Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by Sandoz GmbH for Sandoz, Inc. Princeton, NJ 08540, NDC 00781-3451-70 (vial), NDC 00781-3451-96 (box)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-152-2013·2013-02-13

    Sandoz Recalls Syeda Oral Contraceptives for Incorrect Tablet Imprinting

    Sandoz is recalling Syeda oral contraceptives because some tablets have the wrong ID imprint. Consumers should stop using the affected lot and contact a healthcare provider.

    Product
    Syeda (drospirenone and ethinyl estradiol), 3 mg/0.03 mg, 3 x 28 tablet blistercards, combination oral contraceptive tablet, Manufactured by Laboratorios Leon Farma S.A., Spain for Sandoz Inc., Princeton, NJ
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1678-2012·2012-09-26

    Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity

    Sandoz Incorporated is recalling specific lots of Pramipexole Dihydrochloride Tablets because stability testing revealed an out-of-specification impurity.

    Product
    Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1677-2012·2012-09-26

    Sandoz Recalls Pramipexole Dihydrochloride Tablets Due to Impurity

    Sandoz Incorporated is recalling Pramipexole Dihydrochloride Tablets, 0.25 mg, because an out-of-specification result for a known impurity occurred during stability testing.

    Product
    Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,
    Category
    Drug
    Distribution
    Distributed nationwide