CLASS II Drug recall · Reported 21 Nov 2018 · FDA Enforcement Report
Isosorbide Dinitrate Tablets, USP 20 mg recalled by Sandoz
Sandoz is recalling Isosorbide Dinitrate Tablets, USP 20 mg, distributed nationwide in the US. The recall was initiated on 2 Nov 2018 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0261-2019
- FDA event ID
- 81457
- Recalling firm
- Sandoz, Princeton, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Nov 2018
- FDA classified
- 20 Nov 2018
- Reported
- 21 Nov 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 2 Nov 2018 | Recall initiated by company | |
| 20 Nov 2018 | Classified by FDA | +18 days |
| 21 Nov 2018 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination with Other Products
Product as listed by the FDA
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 was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Cross Contamination with Other Products
Which lots are affected?
Lot #: JA9534, Exp. 05/2021
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 81457This product is part of a recall event; the main page for the event is Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg recalledNitrofurantoin (monohydrate/macrocrystals) | Sandoz | Packaging Defects | Nationwide | |
| CLASS III | Nitrofurantoin Capsules recalled by Sandoz | Sandoz | Other | Nationwide | |
| CLASS II | Isosorbide Dinitrate Tablets, USP 10 mg recalled by Sandoz | Sandoz | Other | Nationwide | |
| CLASS II | Isosorbide Dinitrate Tablets, USP 20 mg recalled by SandozIsosorbide Dinitrate | Sandoz | Other | Nationwide | |
| CLASS II | Isosorbide Dinitrate Tablets, USP 5 mg recalled by Sandoz | Sandoz | Other | Nationwide |
More recalls from Sandoz
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Focalin XR (dexmethylphenidate HCl) 5 mg recalled by SandozFocalin | Sandoz | Other | Nationwide |
| Drug | CLASS II | Cyclophosphamide Injection 500 mg/ (100 mg/mL), Hazardous Drug recalledCyclophosphamide | Sandoz | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension recalledCiprofloxacin And Dexamethasone | Sandoz | Temperature Abuse | CA |
| Drug | CLASS I | Buffered Penicillin G Potassium for Injection recalled by SandozPenicillin G Potassium | Sandoz | Labeling Errors | Nationwide |
| Drug | CLASS I | Cefazolin for Injection, USP per vial, Sterile recalled by SandozCefazolin | Sandoz | Packaging Defects | Nationwide |
Other Isosorbide Dinitrate recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Isosorbide Dinitrate Tablets, USP 5 mg recalled by Sandoz | Sandoz | Other | Nationwide |
| Drug | CLASS II | Isosorbide Dinitrate Tablets, USP 20 mg recalled by SandozIsosorbide Dinitrate | Sandoz | Other | Nationwide |
| Drug | CLASS II | Isosorbide Dinitrate Tablets, USP 10 mg recalled by Sandoz | Sandoz | Other | Nationwide |
| Drug | CLASS II | Isosorbide Dinitrate, Tablet, 10 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Isosorbide Dinitrate, Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |