Sandoz Inc: 43 FDA recall reports
Every drug recall the FDA has published for Sandoz Inc. The fault, and how the agency graded it.
43Reports
3Class I
6Ongoing
2026-06-24Most recent
3 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by So
D-0608-2026 · Class III · reported 2026-06-24 · Ongoing
- Why it was recalled
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Product
- Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottle, Rx only, Manufactured by Societal CDMO Gainesville, LLC, Gainesville, GA 30504. NDC: 66758-235-31
- Where it went
- U.S. Nationwide
- How much
- 7,803 bottles
Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial,
D-0651-2025 · Class II · reported 2025-09-24 · Ongoing
- Why it was recalled
- cGMP deviations: Temperature excursion during transportation.
- Product
- Cyclophosphamide Injection 500 mg/5 mL (100 mg/mL), Hazardous Drug, Rx Only, Sterile, 5mL Multiple Dose Vial, Manufactured in Austria by Fareva Unterach GmbH for Sandoz Inc., Princeton, NJ 08540, Product of India, Vial NDC# 0781-3528-75, Carton NDC# 0781-3528-10.
- Where it went
- Nationwide in the USA
- How much
- 6 vials
Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Nova
D-0626-2025 · Class II · reported 2025-09-17 · Ongoing
- Why it was recalled
- Temperature Abuse
- Product
- Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension Rx Only, For Use in Ears Only, Manufactured By: Novartis Manufacturing NV, Belgium, Distributed by: Sandoz, Inc., Princeton, NJ, NDC# 0781-6186-67, Carton NDC# 0781-6186-67
- Where it went
- Product was distributed to one consignee in CA.
- How much
- 1,680 bottles
Class I
Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufac
D-0569-2025 · Class I · reported 2025-07-09 · Ongoing
- Why it was recalled
- Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin
- Product
- Cefazolin for Injection, USP, 1 gram per vial, Sterile, For Intramuscular or Intravenous Use, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781 3451-70 (vial), NDC: 0781-3451-96 (carton).
- Where it went
- Nationwide in the USA
- How much
- 208,300 vials
Class I
Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, R
D-0570-2025 · Class I · reported 2025-07-09 · Ongoing
- Why it was recalled
- Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit
- Product
- Buffered Penicillin G Potassium for Injection, USP 20,000,000 Units (20 million units), For IV use, Sterile, Rx Only, Manufactured in Austria by Sandoz GmbH for Sandoz Inc. Princeton, NJ 08540, NDC: 0781-6136-94.
- Where it went
- Nationwide in the USA
- How much
- unknown
Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc.,
D-0753-2022 · Class II · reported 2022-04-13 · Terminated
- Why it was recalled
- CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
- Product
- Orphenadrine Citrate Extended-Release Tablets, USP 100 mg, Rx Only, 100 Tablets, Manufactured by Sandoz Inc., Princeton, NJ 08540 NDC 0185-0022-01.
- Where it went
- Nationwide
- How much
- 7908 bottles(790,800 extended release tablets)
Class I
Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcuta
D-0286-2022 · Class I · reported 2021-12-08 · Completed
- Why it was recalled
- Temperature Abuse; temperature excursion during shipping
- 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 Techdow Pharmaceutical Co., Ltd. Shenzhen City, Guangdong Province 518057, China for Sandoz Inc., Princeton, NJ 08540, NDC 00781-3246-64
- Where it went
- Nationwide in the US
- How much
- 45,036 cartons
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only,
D-1259-2020 · Class II · reported 2020-05-13 · Terminated
- Why it was recalled
- Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
- Product
- 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 by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0
- Where it went
- Nationwide within the United States
- How much
- 17,500 units
Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manu
D-0162-2020 · Class III · reported 2019-11-06 · Terminated
- Why it was recalled
- Labeling: Incorrect or missing package insert.
- Product
- Neomycin and Polymyxin B Sulfates and Dexamethasone Ophthalmic Suspension, Rx Only, Sterile, 5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, NDC 61314-630-06
- Where it went
- Nationwide in the U.S.
- How much
- 346,929 bottles
Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured
D-0163-2020 · Class III · reported 2019-11-06 · Terminated
- Why it was recalled
- Labeling: Incorrect or missing package insert.
- Product
- Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL bottle, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540, Product of India, NDC 61314-672-25.
- Where it went
- Nationwide in the U.S.
- How much
- 76,644 bottles
Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL
D-0161-2020 · Class III · reported 2019-11-06 · Terminated
- Why it was recalled
- Labeling: Incorrect or missing package insert.
- Product
- Bimatoprost Ophthalmic Solution 0.03%, Rx Only, For Topical Application to the Upper Eyelid, Sterile, a) 3 mL bottle NDC 0781-6206-93, b) 5 mL bottle NDC 0781-6206-75, Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc., Princeton, NJ 08540, Product of Argentina.
- Where it went
- Nationwide in the U.S.
- How much
- 346,929 bottles
Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ
D-0127-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- Product
- Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
- Where it went
- U.S. Nationwide
- How much
- 100,314 bottles
Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ
D-0128-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- Product
- Sandoz Ranitidine Hydrochloride Capsules 150mg 500 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2855-05
- Where it went
- U.S. Nationwide
- How much
- 13,130 bottles
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 0
D-0129-2020 · Class II · reported 2019-10-16 · Terminated
- Why it was recalled
- CGMP Deviations: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
- Product
- Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31
- Where it went
- U.S. Nationwide
- How much
- 136,788 bottles
Sandoz Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 1000-count bottles, Rx Only, Fin
D-0359-2019 · Class II · reported 2018-12-05 · Ongoing
- Why it was recalled
- CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
- 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.
- Where it went
- OH, PR
- How much
- 170 HDPE bottles
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-
D-0257-2019 · Class III · reported 2018-11-21 · Terminated
- Why it was recalled
- Cross Contamination with Other Products
- Product
- Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, packaged in a) 100-capsule bottles (NDC 0185-0122-01); and b) 1000-capsule bottles, (NDC 0185-0122-10); Rx Only, Distributed by Sandoz Inc. Princeton, NJ 08540
- Where it went
- Nationwide within the United States
- How much
- 14366 bottles
Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg, 100-count bottoles, Rx Only, Manufactured for
D-0262-2019 · Class III · reported 2018-11-21 · Terminated
- Why it was recalled
- 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
- Where it went
- Nationwide within the United States
- How much
- 23053 bottles
Isosorbide Dinitrate Tablets, USP 20 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ
D-0261-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- 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
- Where it went
- Nationwide within the United States
- How much
- 1550 bottles
Isosorbide Dinitrate Tablets, USP 10 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ
D-0260-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- 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
- Where it went
- Nationwide within the United States
- How much
- 5100 bottles
Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ
D-0258-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- Cross Contamination with Other Products
- Product
- Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01
- Where it went
- Nationwide within the United States
- How much
- 18,832 bottles
Isosorbide Dinitrate Tablets, USP 5 mg,100-count bottles, Rx Only Manufactured by: Sandoz Inc., Princeton, NJ
D-0259-2019 · Class II · reported 2018-11-21 · Terminated
- Why it was recalled
- Cross Contamination with Other Products
- 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
- Where it went
- Nationwide within the United States
- How much
- 7817 bottles
Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wra
D-1179-2017 · Class III · reported 2017-10-04 · Terminated
- Why it was recalled
- Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
- Product
- Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 13,435 shrink wrap packs
Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured
D-0868-2017 · Class III · reported 2017-06-07 · Terminated
- Why it was recalled
- Subpotent Drug; Clavulanic Acid
- Product
- Amoxicillin and Clavulanate Potassium Tablets, USP, 500 mg/125 mg, in 20 count bottles, Rx Only, Manufactured in Austria by Sandoz Gmbh for Sandoz Inc. Princeton NJ NDC 0781-1831-20
- Where it went
- NY, OH
- How much
- 4,464 bottles
Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg, 30 count bottles, Rx only, Manufactured by Lek Pharmace
D-0515-2017 · Class II · reported 2017-03-15 · Terminated
- Why it was recalled
- Failed 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
- Where it went
- Nationwide
- How much
- N/A
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (NDC 66758-208-58), packaged in 4-c
D-0481-2017 · Class II · reported 2017-03-01 · Terminated
- Why it was recalled
- Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stating "Do cut the patch" rather than the correct instructions of "Do not cut the patch". The pouch containing the patch is labeled correctly.
- 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.
- Where it went
- Nationwide in the USA and Puerto Rico
- How much
- 157,922 cartons
Donepezil Hydrochloride Tablets, 10 mg, packaged in a) 30-count bottles (NDC 0781-5275-31) and b) 1000-count b
D-0435-2017 · Class III · reported 2017-01-25 · Terminated
- Why it was recalled
- Subpotent Drug: out of specification results for assay test.
- 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.
- Where it went
- Nationwide in the USA
- How much
- a) 10,200 bottles; b) 300 bottles
Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: San
D-0145-2017 · Class III · reported 2016-11-30 · Terminated
- Why it was recalled
- Labeling: Missing Label
- Product
- Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01
- Where it went
- WI
- How much
- 139,430 vials
L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packa
D-0141-2017 · Class II · reported 2016-11-23 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product 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.
- Where it went
- Nationwide throughout the USA
- How much
- 33,624 vials
L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), pa
D-0140-2017 · Class II · reported 2016-11-23 · Terminated
- Why it was recalled
- Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product 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.
- Where it went
- Nationwide throughout the USA
- How much
- 18,751 vials
Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 24 patches Multi pack, Rx only, Marketed by Baxter He
D-0133-2017 · Class II · reported 2016-11-16 · Terminated
- Why it was recalled
- Defective Delivery System; reports of damaged product that may alter the predicted release of scopolamine following transdermal application.
- 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
- Where it went
- TN
- How much
- 42,740 cartons (24 count carton from 7 total lots)
Showing the 30 most recent of 43. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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