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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sandoz Inc: Various Nitrofurantoin and Isosorbide Dinitrate Medications Recalled

Agency Publication Date: November 15, 2018
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Summary

Sandoz Inc. has recalled approximately 70,718 bottles of several prescription medications, including Nitrofurantoin (100 mg) and Isosorbide Dinitrate (5 mg, 10 mg, and 20 mg), due to concerns regarding cross-contamination with other products. These medications are used to treat urinary tract infections and chest pain (angina). If you are taking these medications, contact your doctor or pharmacist immediately to determine if your supply is part of the recall and to arrange for a safe replacement.

Risk

The medications may have been contaminated with other drug products during the manufacturing process, which could cause patients to ingest unintended active ingredients. This cross-contamination can lead to unexpected side effects or reduced effectiveness of the primary treatment.

What You Should Do

  1. Check your prescription bottle label for the following National Drug Codes (NDC): 0185-0122-01, 0185-0122-10, 0781-1695-01, 68001-223-00, 68001-225-00, 68001-222-00, or 16714-439-01.
  2. Identify if your medication lot number matches any of the following: Nitrofurantoin (JB4952, JA7322, JA7324, JA7319, JA7320, JA7321); Isosorbide Dinitrate (JA9535, HZ7896, JA3077, JA9534).
  3. If your medication is affected, contact your healthcare provider or pharmacist immediately for guidance on continued use and to obtain a replacement prescription.
  4. Return any unused, affected medication to your pharmacy to receive a refund.
  5. Contact Sandoz Inc. for further instructions or questions regarding this recall at their corporate office in Princeton, NJ.
  6. For additional questions or to report an adverse event, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg (100-capsule bottles)
Model:
NDC 0185-0122-01
Lot Numbers:
JB4952 (Exp. 03/2020)
JA7322 (Exp. 03/2020)
Date Ranges: Exp. 03/2020
Product: Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg (1000-capsule bottles)
Model:
NDC 0185-0122-10
Lot Numbers:
JA7324 (Exp. 03/2020)
Date Ranges: Exp. 03/2020
Product: Isosorbide Dinitrate Tablets, USP 20 mg (100-count bottles)
Model:
NDC 0781-1695-01
Lot Numbers:
JA9535 (Exp. 05/2021)
Date Ranges: Exp. 05/2021
Product: BluePoint Laboratories Isosorbide Dinitrate Tablets, USP 5 mg (100-count bottles)
Model:
NDC 68001-223-00
Lot Numbers:
HZ7896 (Exp. 05/2021)
Date Ranges: Exp. 05/2021
Product: BluePoint Laboratories Isosorbide Dinitrate Tablets, USP 10 mg (100-count bottles)
Model:
NDC 68001-225-00
Lot Numbers:
JA3077 (Exp. 05/2021)
Date Ranges: Exp. 05/2021
Product: BluePoint Laboratories Isosorbide Dinitrate Tablets, USP 20 mg (100-count bottles)
Model:
NDC 68001-222-00
Lot Numbers:
JA9534 (Exp. 05/2021)
Date Ranges: Exp. 05/2021
Product: Northstar Rx LLC Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100 mg (100-count bottles)
Model:
NDC 16714-439-01
Lot Numbers:
JA7319 (Exp. 03/2020)
JA7320 (Exp. 03/2020)
JA7321 (Exp. 03/2020)
Date Ranges: Exp. 03/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81457
Status: Resolved
Manufacturer: Sandoz Inc
Sold By: Pharmacies; Northstar Rx LLC; BluePoint Laboratories
Manufactured In: United States
Units Affected: 6 products (14366 bottles; 18,832 bottles; 7817 bottles; 5100 bottles; 1550 bottles; 23053 bottles)
Distributed To: Nationwide
Agency Last Updated: November 26, 2018

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.