Sandoz Inc recalls
Every recall we track for Sandoz Inc — 43 in all, from 2013–2026 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Sandoz Inc peaked in 2018 (7); 25 since 2017.
All FDA recall records for Sandoz Inc since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 4 | 0 | 4 |
| 2018 | 0 | 0 | 4 | 3 | 7 |
| 2019 | 0 | 0 | 4 | 2 | 6 |
| 2020 | 0 | 0 | 1 | 0 | 1 |
| 2021 | 0 | 0 | 1 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 1 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 2 | 2 | 0 | 4 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
Sandoz Inc recalls before 2017
Recalls on record by year.
Most common reasons for Sandoz Inc recalls
What to do if you have a recalled Sandoz Inc product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All Sandoz Inc recalls
30 shown- Lower riskDrug
Sandoz Inc recalls Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal
Sandoz recalls Focalin XR 5mg capsules due to missing lot and expiration dates. Affected units may pose safety risks if not properly labeled.
SandozJun 1, 2026 - Lower riskDrug
Sandoz Inc recalls Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial,
Sandoz recalls specific lots of Cyclophosphamide Injection due to temperature issues during shipping that could affect drug safety.
SandozSep 5, 2025 - Use cautionDrug
Sandoz Inc recalls Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis
Sandoz recalls Ciprofloxacin 0.3% and Dexamethasone 0.1% ear drops due to temperature abuse risks. This prescription-only ear medication may cause injury if stored or used improperly.
SandozAug 13, 2025 - Use cautionDrug
Sandoz Inc recalls Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by
Sandoz recalls Cefazolin injections due to label mix-up with penicillin vials. Affected lots may contain incorrect medication. Stop using if unsure.
SandozJun 27, 2025 - UnratedDrug
Sandoz, Inc recalls Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc.,
Sandoz recalls 100-mg extended-release orphenadrine tablets with nitrosamine impurities above safe limits. Affected lots from 2022-2023 may pose health risks. Consumers should contact Sandoz for details.
SandozMar 21, 2022 - Lower riskDrug
Sandoz Inc recalls Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous
Sandoz recalls 40mg enoxaparin syringes due to temperature issues during shipping that could affect safety. Learn if your product is affected and what to do.
SandozNov 17, 2021 - Lower riskDrug
Sandoz, Inc recalls Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed
Sandoz recalls pediatric Infuvite vitamin kits due to sub-optimal vial crimping. This may cause leaks or contamination. Affected kits have NDC 54643-5647-0, lot JX907, expiring 02/2021.
SandozApr 21, 2020 - Lower riskDrug
Sandoz Inc recalls Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured
Sandoz recalls Neomycin and Polymyxin B Sulfates with Dexamethasone ophthalmic suspension due to incorrect or missing package inserts. This affects specific 5mL bottles manufactured in 2019-2021.
SandozOct 17, 2019 - UnratedDrug
Sandoz, Inc recalls Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of
Sandoz recalls 150mg ranitidine capsules due to trace N-nitrosodimethylamine (NDMA) impurity. This may pose health risks. Consumers should contact Sandoz for details.
SandozSep 23, 2019 - Lower riskDrug
Sandoz Inc recalls Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01);
Sandoz recalls 100mg Nitrofurantoin Capsules due to cross contamination risk. Affected lots expire March 2020. Consumers should contact Sandoz for details.
SandozNov 2, 2018 - Lower riskDrug
Sandoz, Inc recalls Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Finished Drug
Sandoz recalls 1000-count bottles of Losartan Potassium and Hydrochlorothiazide tablets due to FDA-confirmed NDEA impurity exceeding safe levels. Affected lots contain a potential cancer risk.
SandozNov 1, 2018 - Lower riskDrug
Sandoz Inc recalls Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs
Sandoz recalls 10-count packs of Ampicillin injections (500mg/vial) due to missing labels on some vials. This could lead to incorrect dosing if used without proper labeling.
SandozSep 25, 2017 - Lower riskDrug
Sandoz Inc recalls Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in
Sandoz recalls 500mg/125mg amoxicillin-clavulanate tablets (20-count) due to subpotent clavulanic acid. This may reduce effectiveness of the antibiotic. Contact Sandoz for details.
SandozApr 26, 2017 - Lower riskDrug
Sandoz Inc recalls Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmaceuticals
Sandoz recalls 30 mg/4 mg Pioglitazone-Glimepiride tablets with failed dissolution specs. Rx-only bottles manufactured by Lek Pharmaceuticals in Slovenia. Check NDC 0781-5635-31, Lot FY3669 (exp 11/2017).
SandozFeb 10, 2017 - Lower riskDrug
Sandoz Inc recalls Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-count
Sandoz recalls Transderm Scop 1.5mg patches due to incorrect instructions in carton. This could lead to accidental cutting of the patch, which may cause injury. Affected products were sold with specific lot numbers and expiration dates.
SandozFeb 2, 2017 - Lower riskDrug
Sandoz Inc recalls Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count bottles
Sandoz recalls 10mg Donepezil tablets with subpotent drug results. Affected lots expire May 2017. No remedy specified in official notice.
SandozDec 13, 2016 - Lower riskDrug
Sandoz Inc recalls L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5
Sandoz recalls pharmacy bulk vials of L-Cysteine Hydrochloride Injection due to potential sterility issues from FDA inspection concerns. Affected lots expire by July 2017.
SandozNov 9, 2016 - Lower riskDrug
Sandoz Inc recalls Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH
Sandoz recalls 1g Ceftriaxone injection vials due to missing labels. This affects patients using the medication for infections. Contact Sandoz for details.
SandozOct 19, 2016 - UnratedDrug
Sandoz Inc recalls 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
Sandoz recalls phenylephrine injections due to potential sterility issues found during FDA inspection. Products with specific NDC numbers and expiration dates are affected. Consumers should contact Sandoz for details.
SandozAug 24, 2016 - Lower riskDrug
Sandoz Inc recalls Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter Healthcare
Sandoz recalls Transderm Scop 1.5mg 24-patch multi-packs due to defective delivery system that may alter scopolamine release. Affected units have specific NDC and lot numbers. Contact Sandoz for details.
SandozAug 24, 2016 - Use cautionDrug
Sandoz Inc recalls Lisinopril Tablets USP, 30 mg, 100-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, NDC
Sandoz recalls 3,048 bottles of Lisinopril 30mg tablets because the package insert is incorrect or missing. Check your lot number and expiration date.
SandozMay 25, 2016 - Use cautionDrug
Sandoz, Inc recalls Dicloxacillin Sodium Capsules USP, 500mg, Rx Only, 100 Capsule bottle, Manufactured in Austria by Sandoz Gmbh,
Sandoz recalls specific lots of 500mg Dicloxacillin Sodium Capsules due to failed impurity specifications. Check your bottle's lot number and expiration date.
SandozMay 2, 2016 - Use cautionDrug
Sandoz Inc recalls Candesartan Cilexetil Tablets, 16 mg, a) 30 count (NDC 00781-5938-31) and b) 90 count (NDC 00781-5938-92) bottles, Rx
Sandoz recalls specific lots of Candesartan Cilexetil Tablets, 16 mg, due to failed impurity specifications. Check your NDC and lot numbers.
SandozDec 31, 2015 - Use cautionDrug
Sandoz, Inc recalls Cetirizine HCl Chewable Tablet, 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count
Sandoz recalls over 1 million units of Cetirizine HCl chewable tablets due to failed impurity specifications. Check lot numbers and expiration dates.
SandozApr 15, 2015 - Use cautionDrug
Sandoz, Inc recalls candesartan cilexetil, tablets, 16 mg, 90-count bottles, Rx only, Manufactured for Sandoz Inc., Princeton, NJ 08540 by
Sandoz recalls specific lots of 16 mg candesartan cilexetil tablets due to failed impurity specifications. Check your bottle's lot number and expiration date.
SandozOct 2, 2014 - Use cautionDrug
Sandoz Inc recalls Orphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC
Sandoz Inc. recalls specific lots of Orphenadrine Citrate Extended Release Tablets, 100 mg, because they failed dissolution specifications during stability testing.
SandozJul 11, 2014 - Stop using nowDrug
Sandoz, Inc recalls Cefpodoxime Proxetil Tablets, USP, 200 mg, 20 Tablet Bottles, Rx Only. Manufactured in Austria by Sandoz GmbH for
Sandoz recalls specific lots of Cefpodoxime Proxetil Tablets, USP 200 mg due to the presence of stainless steel particles. Check your bottle's lot number.
SandozMay 22, 2014 - UnratedDrug
Sandoz Inc recalls Bumetanide Tablets USP 0.5 mg. Rx Only, a) 100-count Bottle, b) 500-count Bottle, Sandoz Inc., Princeton, NJ 08540, NDC
Sandoz recalls specific lots of Bumetanide Tablets USP 0.5 mg due to failed moisture limits. Check your bottle's lot number and NDC for details.
SandozNov 6, 2013 - Use cautionDrug
Sandoz Inc recalls Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540
Sandoz recalls specific lots of Fosinopril Sodium and Hydrochlorothiazide Tablets due to subpotent Hydrochlorothiazide levels.
SandozOct 11, 2013 - Stop using nowDrug
Sandoz, Inc recalls Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for
Sandoz recalls specific lots of Ropinirole 2mg extended-release tablets due to potential cross-contamination with mycophenolate mofetil.
SandozOct 9, 2013
Sandoz Inc recall questions
How many recalls has Sandoz Inc had?
43 recalls from Sandoz Inc are on record with U.S. safety agencies, from 2013–2026.
What is the most recent Sandoz Inc recall?
Sandoz Inc recalls Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal, dated Jun 1, 2026. Every Sandoz Inc recall is listed on this page, newest first.
Why are Sandoz Inc products recalled?
The most common reasons on record: Cross Contamination with Other Products (6); Labeling: Incorrect or missing package insert. (3).
What should I do if I have a recalled Sandoz Inc product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new Sandoz Inc recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.