Novartis Pharmaceuticals Corp. recalls
Every recall we track for Novartis Pharmaceuticals Corp. — 26 in all, from 2013–2023 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
4 recalls since 2017.
All FDA recall records for Novartis Pharmaceuticals Corp. 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 | 0 | 2 | 2 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Novartis Pharmaceuticals Corp. recalls before 2017
Recalls on record by year.
Most common reasons for Novartis Pharmaceuticals Corp. recalls
What to do if you have a recalled Novartis Pharmaceuticals Corp. 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 Novartis Pharmaceuticals Corp. recalls
9 shown- Lower riskDrug
Novartis Pharmaceuticals Corp. recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM
Novartis recalls Sandimmune Oral Solution (100 mg/mL, 50mL bottle) due to crystallization in bottles. This may affect immunosuppressant medication safety for patients with organ transplants.
NovartisSep 8, 2023 - Lower riskDrug
Novartis Pharmaceuticals Corp. recalls Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New
Novartis recalls Promacta 12.5 mg oral suspension (Rx only) due to possible cross-contamination with peanut flour. Affected lots manufactured by Halo Pharmaceuticals in New Jersey.
NovartisMay 11, 2019 - UnratedDrug
Novartis Pharmaceuticals Corp. recalls Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only, Manufactured by:
Novartis recalls Isopto Carpine 4% eye drops due to failed impurity specifications. Check lot 244661F, exp Feb 2018.
IsoptoMar 22, 2017 - Use cautionDrug
Novartis Pharmaceuticals Corp. recalls Dexmethylphenidate HCl Extended-Release, Capsules, 10mg, Rx only, 100 Capsules. Manufactured by Alkermes Gainesville
Sandoz recalls 10,767 bottles of Dexmethylphenidate HCl Extended-Release Capsules due to failed dissolution specifications. Check your lot number.
SandozJul 28, 2015 - UnratedDrug
Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder) 12 mcg per capsule, 60 Capsules (Blister strips of 6) per
Novartis recalls Foradil Aerolizer (12 mcg) due to failed particle size distribution stability testing. Check lot F0082, exp May 2015.
NovartisMay 22, 2015 - Lower riskDrug
Novartis Pharmaceuticals Corp. recalls Cataflam (diclofenac potassium) tablets, 50 mg, 100-count bottles, Rx only, Manufactured by: Patheon Inc., Whitby
Novartis recalls 50 bottles of Cataflam tablets because ink identification rubbed off, making them illegible. Check your lot numbers and expiration dates.
NovartisJul 30, 2014 - UnratedDrug
Novartis Pharmaceuticals Corp. recalls Foradil Aerolizer (formoterol fumarate inhalation powder), 12 mcg per capsule, 60 Capsules, Rx only, Manufactured for:
Novartis recalls specific lots of Foradil Aerolizer inhalation powder due to failed stability specifications. Check your lot numbers immediately.
NovartisMay 28, 2014 - Lower riskDrug
Novartis Pharmaceuticals Corp. recalls Ritalin HCl (methylphenidate HCl) USP, 10 mg, 100 tablets per Bottle, Rx only, Mfd. by: Novartis Pharmaceuticals Corp.
Novartis recalls 10,930 bottles of Ritalin HCl 10mg tablets because the attached Medication Guide contains incorrect information for Ritalin SR.
NovartisMar 3, 2014 - Stop using nowDrug
Novartis Pharmaceuticals Corp. recalls Exforge HCT (amlodipine, valsartan, hydrochlorothiazide) 5/160/25 mg, Rx only, 7 tablets per bottle, Physician Sample -
Novartis recalls physician sample bottles of Exforge HCT due to contamination with Darocur 1173. Check lot numbers F0012, F0013, and F0014.
NovartisAug 8, 2013
Novartis Pharmaceuticals Corp. recall questions
How many recalls has Novartis Pharmaceuticals Corp. had?
26 recalls from Novartis Pharmaceuticals Corp. are on record with U.S. safety agencies, from 2013–2023.
What is the most recent Novartis Pharmaceuticals Corp. recall?
Novartis Pharmaceuticals Corp. recalls SANDIMMUNE Oral Solution (cyclosporine oral solution, USP) 100 mg/mL, 50 mL bottle, Rx Only, Manufactured by: DELPHARM, dated Sep 8, 2023. Every Novartis Pharmaceuticals Corp. recall is listed on this page, newest first.
Why are Novartis Pharmaceuticals Corp. products recalled?
The most common reasons on record: Failed Impurities/Degradation Specifications. (2).
What should I do if I have a recalled Novartis Pharmaceuticals Corp. 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 Novartis Pharmaceuticals Corp. 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.