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.

26–43 of 43

  • ModerateFDA (Drugs)·D-0435-2017·2017-01-25

    Sandoz Recalls Subpotent Donepezil Hydrochloride Tablets

    Sandoz Inc. is recalling specific lots of Donepezil Hydrochloride 10 mg tablets because they failed potency tests. The medication may not contain the full prescribed dose.

    Product
    Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles (NDC 0781-5275-10), Rx only, Manufactured in India by Sandoz Private Ltd for Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0145-2017·2016-11-30

    Sandoz Recalls Ceftriaxone Sodium Vials Due to Missing Labels

    Sandoz Inc is recalling 139,430 vials of Ceftriaxone Sodium for Injection in Wisconsin due to missing labels.

    Product
    CEFTRIAXONE SODIUM — CEFTRIAXONE SODIUM (CEFTRIAXONE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0140-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0141-2017·2016-11-23

    Sandoz Recalls L-Cysteine Hydrochloride Injection Due to Sterility Concerns

    Sandoz Inc. is recalling L-Cysteine Hydrochloride Injection vials because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0133-2017·2016-11-16

    Sandoz Recalls Transderm Scop Patches Due to Defective Delivery System

    Sandoz Inc is recalling 42,740 cartons of Transderm Scop (scopolamine) transdermal systems in Tennessee due to a defective delivery system that may alter drug release.

    Product
    Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare Cop/Novartis, Deerfield, IL 60015, Manufactured by:Alza Corporation, Vacaville, CA 95688 for Novartis Consumer Health Inc., Parsippany, NJ 07054
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1514-2016·2016-09-28

    Sandoz Recalls Phenylephrine Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Phenylephrine HCI Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Phenylephrine HCI Injection, USP, 10mg/mL, packaged in a) 5 mL Vial, 50 mg/5 mL (NDC 66758-016-03), 25 x 5 mL Vials per carton (NDC 66758-016-04) and b) 10 mL Vials, 100 mg/10 mL (NDC 66758-017-01), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1513-2016·2016-09-28

    Sandoz Recalls Ephedrine Sulfate Injection Due to Sterility Concerns

    Sandoz Inc. is recalling specific lots of Ephedrine Sulfate Injection because an FDA inspection raised concerns that the product's sterility may be compromised.

    Product
    Ephedrine Sulfate Injection, USP, 50 mg/mL, 1 mL Fill in a 2mL Vial (NDC 66758-008-01), packaged in 25 x 2 mL Vials per carton (NDC 66758-008-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1046-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Test Failure

    Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.

    Product
    Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc. , Princeton, NJ 08540, Product of Spain, NDC 0781-2258-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1045-2016·2016-06-29

    Sandoz Recalls Dicloxacillin Sodium Capsules Due to Impurity Testing Failures

    Sandoz, Inc. is recalling Dicloxacillin Sodium Capsules because testing revealed out-of-specification results for a known impurity.

    Product
    Dicloxacillin Sodium Capsules, USP 250mg, Rx Only, 100 Capsule Bottle, Manufactured in Austria by Sandoz Gmbh, Distributed by Sandoz Inc., Princeton, NJ 08540, Product of Spain, NDC 0781-2248-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1036-2016·2016-06-22

    Sandoz Recalls Lisinopril Tablets Due to Missing Package Insert

    Sandoz Inc is recalling 3,048 bottles of Lisinopril Tablets USP, 30 mg, because the package insert is incorrect or missing.

    Product
    Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC 0185-0630-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0659-2016·2016-02-17

    Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Sandoz Inc. is recalling Candesartan Cilexetil Tablets, 16 mg, because the product failed impurities and degradation specifications at a 9-month stability timepoint.

    Product
    Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx Only, Manufactured by Mylan Laboratories Limited Hyderabad 500 034, India for Sandoz Inc. Princeton, NJ 08540
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1115-2015·2015-06-10

    Sandoz Recalls Cetirizine HCl Chewable Tablets Due to Impurity Failure

    Sandoz, Inc. is recalling specific lots of Cetirizine HCl Chewable Tablets because an impurity exceeded specifications during stability testing.

    Product
    Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. Manufactured by Sandoz Private Limited Village-Digham Opp. Thane-Belapur Road Navi Mumbai, 400 078, India, for Sandoz Private Limited 100 College R
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0288-2015·2014-12-10

    Sandoz Recalls Candesartan Cilexetil Tablets Due to Impurity Failures

    Sandoz, Inc. is recalling 6,336 bottles of 16 mg candesartan cilexetil tablets because stability testing showed impurity levels exceeded specifications.

    Product
    candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by Mylan Laboratories Limited Hyderabad, 500 034, India, NDC 0781-5938-92
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1445-2014·2014-07-30

    Sandoz Recalls Orphenadrine Citrate Tablets for Dissolution Failures

    Sandoz Inc. is recalling Orphenadrine Citrate Extended Release Tablets because they failed dissolution specifications during stability testing.

    Product
    ORPHENADRINE CITRATE — ORPHENADRINE CITRATE (ORPHENADRINE CITRATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1350-2014·2014-06-04

    Sandoz Recalls Cefpodoxime Proxetil Tablets Due to Stainless Steel Particles

    Sandoz, Inc. is recalling Cefpodoxime Proxetil tablets because they contain stainless steel particles. The recall covers 22,818 bottles distributed nationwide.

    Product
    CEFPODOXIME PROXETIL — CEFPODOXIME PROXETIL (CEFPODOXIME PROXETIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-393-2014·2014-01-08

    Sandoz Recalls Subpotent Fosinopril Sodium and Hydrochlorothiazide Tablets

    Sandoz Inc. is recalling specific lots of Fosinopril Sodium and Hydrochlorothiazide tablets because the hydrochlorothiazide content was subpotent at the 9-month time point.

    Product
    Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-66458-1·2013-11-13

    Sandoz Recalls Ropinirole Extended-Release Tablets Due to Cross-Contamination

    Sandoz is recalling specific lots of Ropinirole Extended-Release Tablets 2 mg due to potential cross-contamination with mycophenolate mofetil.

    Product
    Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92
    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.