The Recall Desk

Manufacturer

Sandoz, Inc

43 recalls in our database name Sandoz, Inc as the manufacturing or recalling firm.

What the numbers show

Total
43
Critical
0
Severe
16
Most recent
2026-06-24

Of the 43 recalls from Sandoz, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 16 (37%) 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.

1–25 of 43

  • LowFDA (Drugs)·D-0608-2026·2026-06-24

    Focalin XR 5mg capsules carry incorrect or missing lot and expiry

    Focalin XR 5 mg extended-release capsules are being recalled over a labeling issue: incorrect or missing lot number and/or expiry date. 7,803 bottles are affected.

    Product
    FOCALIN — FOCALIN (DEXMETHYLPHENIDATE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0626-2025·2025-09-17

    Ciprofloxacin and dexamethasone otic suspension recalled following temperature abuse

    Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, lot VNF35A, distributed by Sandoz, is recalled because of temperature abuse. 1,680 bottles went to a single consignee in California.

    Product
    CIPROFLOXACIN AND DEXAMETHASONE — CIPROFLOXACIN AND DEXAMETHASONE (CIPROFLOXACIN AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0570-2025·2025-07-09

    Buffered penicillin G potassium vials may actually contain cefazolin for injection

    Buffered Penicillin G Potassium for Injection is being recalled because some vials of cefazolin for injection were incorrectly labeled as penicillin G potassium 20 million units.

    Product
    PENICILLIN G POTASSIUM — PENICILLIN G POTASSIUM (PENICILLIN G POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0753-2022·2022-04-13

    FDA Recalls Orphenadrine Citrate Tablets Due to Nitrosamine Impurity

    Sandoz is recalling Orphenadrine Citrate Extended-Release Tablets due to nitrosamine impurity levels exceeding acceptable daily limits. Affected patients should consult their healthcare provider.

    Product
    ORPHENADRINE CITRATE — ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0286-2022·2021-12-08

    Sandoz Enoxaparin Sodium Injection Recalled Due to Temperature Excursion

    Sandoz Inc. is recalling 45,036 cartons of Enoxaparin Sodium Injection USP 40 mg/0.4 mL due to temperature abuse during shipping. The affected lot was distributed nationwide.

    Product
    Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Rx Only; 0.4 mL Syringes, Manufactured for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-02; Carton (10 x 0.4 mL Syringes), Manufactured by Shenzhen T
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1259-2020·2020-05-13

    Sandoz Recalls Infuvite Pediatric Injection Due to Defective Container Crimping

    Sandoz is recalling 17,500 units of Infuvite Pediatric Multiple Vitamins Injection due to sub-optimal crimping in the vial. The product was distributed nationwide.

    Product
    INFUVITE PEDIATRIC — INFUVITE PEDIATRIC (MULTIPLE VITAMINS INJECTION)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0161-2020·2019-11-06

    Sandoz Recalls Bimatoprost Ophthalmic Solution Due to Missing Package Insert

    Sandoz Inc is recalling Bimatoprost Ophthalmic Solution 0.03% because the package insert is incorrect or missing. The recall covers 346,929 bottles distributed nationwide.

    Product
    BIMATOPROST — BIMATOPROST (BIMATOPROST)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0162-2020·2019-11-06

    Sandoz Recalls Neomycin and Polymyxin B Ophthalmic Suspension for Labeling Error

    Sandoz Inc. is recalling 346,929 bottles of Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension due to incorrect or missing package inserts.

    Product
    NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE — NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE (NEOMYCIN SULFATE, POLYMYXIN B SULFATE AND DEXAMETHASONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0128-2020·2019-10-16

    Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Sandoz is recalling 13,130 bottles of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.

    Product
    Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0129-2020·2019-10-16

    Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity Detection

    Sandoz is recalling Ranitidine Hydrochloride Capsules 300mg because a trace amount of the impurity NDMA was detected.

    Product
    Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0127-2020·2019-10-16

    Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity

    Sandoz is recalling specific lots of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.

    Product
    Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0359-2019·2018-12-05

    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets Recalled for NDEA Impurity

    Sandoz is recalling Losartan Potassium and Hydrochlorothiazide tablets because FDA testing found the impurity NDEA above acceptable levels.

    Product
    Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug Product Manufactured by: Lek Pharmaceuticals d.d. SI-1526 Ljubljana,Sovenia for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5207-10.
    Category
    Drug
    Distribution
    2 states
  • SevereFDA (Drugs)·D-0261-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 1,550 bottles of Isosorbide Dinitrate Tablets 20 mg due to cross-contamination with other products.

    Product
    Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-222-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0260-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 5,100 bottles of Isosorbide Dinitrate Tablets, USP 10 mg, due to cross contamination with other products.

    Product
    Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-225-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0259-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling Isosorbide Dinitrate Tablets 5 mg due to cross-contamination with other products. The recall affects 7,817 bottles distributed nationwide.

    Product
    Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ 08540 For BluePoint Laboratories, NDC 68001-223-00
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0258-2019·2018-11-21

    Sandoz Recalls Isosorbide Dinitrate Tablets Due to Cross Contamination

    Sandoz Inc. is recalling 18,832 bottles of Isosorbide Dinitrate 20 mg tablets due to cross-contamination with other products.

    Product
    ISOSORBIDE DINITRATE — ISOSORBIDE DINITRATE (ISOSORBIDE DINITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0257-2019·2018-11-21

    Sandoz Recalls Nitrofurantoin Capsules Due to Cross Contamination

    Sandoz Inc is recalling specific lots of Nitrofurantoin capsules because they may be cross-contaminated with other products.

    Product
    NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) — NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS) (NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS))
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0262-2019·2018-11-21

    Sandoz Recalls Nitrofurantoin Capsules Due to Cross-Contamination

    Sandoz Inc. is recalling specific lots of Nitrofurantoin Capsules 100 mg due to cross-contamination with other products.

    Product
    Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for: Northstar Rx LLC Memphis, TN 38141 Manufactured by: Sandoz Inc. Princeton, NJ 08540,NDC 16714-439-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1179-2017·2017-10-04

    Sandoz Recalls Ampicillin Vials Due to Missing Labels

    Sandoz Inc is recalling 13,435 packs of Ampicillin for Injection because some vials are missing labels. The recall covers distribution in the USA and Puerto Rico.

    Product
    AMPICILLIN — AMPICILLIN (AMPICILLIN SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0868-2017·2017-06-07

    Sandoz Recalls Subpotent Amoxicillin and Clavulanate Potassium Tablets

    Sandoz Inc is recalling 4,464 bottles of Amoxicillin and Clavulanate Potassium tablets found to be subpotent in clavulanic acid.

    Product
    AMOXICILLIN AND CLAVULANATE POTASSIUM — AMOXICILLIN AND CLAVULANATE POTASSIUM (AMOXICILLIN AND CLAVULANATE POTASSIUM)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0515-2017·2017-03-15

    Sandoz Recalls Pioglitazone and Glimepiride Tablets Due to Dissolution Failure

    Sandoz Inc is recalling specific lots of Pioglitazone and Glimepiride Tablets because they failed to meet dissolution specifications.

    Product
    Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals d.d., Verovskova Ulica 57, Ljubljana, - SI-1526, Slovenia --- NDC 0781-5635-31
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0481-2017·2017-03-01

    Sandoz Recalls Transderm Scop Patches Due to Incorrect Labeling Instructions

    Sandoz Inc. is recalling Transderm Scop patches because the outer carton contains incorrect instructions for cutting the patch.

    Product
    Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count patches per carton (NDC 66758-208-54), Rx Only, Manufactured by ALZA Corporation, Vacaville, CA 95688 for Sandoz Inc., Princeton, NJ 08540.
    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.

Sandoz

pharmaceutical company

Country
Switzerland
Founded
1886
Parent company
Novartis

Official website

Source: Wikidata (Q528468), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.