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.
Lower-risk recall
Cross Contamination with Other Products
Contact the company & request your remedy
What happened, in plain English
Sandoz is recalling 100mg Nitrofurantoin Capsules that may have been contaminated with other products. This could lead to unintended medication effects if taken. The recall affects specific bottle sizes and expiration dates. Read more at govinfonow.com/recall/39445-sandoz-nitrofurantoin-capsules-recall-cross-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39445-sandoz-nitrofurantoin-capsules-recall-cross-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0257-2019
Cite this page
“Sandoz Nitrofurantoin Capsules Recall: Cross Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39445-sandoz-nitrofurantoin-capsules-recall-cross-contamination-risk. Based on FDA recall #D-0257-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0257-2019%22&limit=1).
Why it’s dangerous
The capsules may have been contaminated with other products during manufacturing. This could lead to unintended medication effects if taken, but the risk is low and not life-threatening.
Who’s affected
People with prescriptions for 100mg Nitrofurantoin Capsules from Sandoz Inc. The risk is low as the contamination is unlikely to cause serious harm.
How to tell if you have this one
Check for 100-capsule bottles (NDC 0185-0122-01) or 1000-capsule bottles (NDC 0185-0122-10) with expiration dates of March 2020.
- Brand
Sandoz- Category
Drug
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Status
Terminated- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | Class | NDC |
|---|---|---|---|---|
| D-0257-2019 | 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; Lots: a) JB4952, JA7322 Exp. 03/2020; b) JA7324, Exp.03/2020 | 14366 bottles | Class III | 0185-0122-01, 0185-0122-10 |
| D-0258-2019 | Isosorbide Dinitrate Tablets, USP 20 mg, 100-count bottles, Rx Only, Distributed by: Sandoz Inc. Princeton, NJ 08540; NDC 0781-1695-01; Lots: a) JA9535 Exp. 05/2021. | 18,832 bottles | Class II | 0781-1635-10, 0781-1635-01, 0781-1635-13, 0781-1556-01, 0781-1556-05, 0781-1556-10, 0781-1556-13, 0781-1695-13, 0781-1695-10, 0781-1695-01 |
| D-0259-2019 | 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; Lot #: HZ7896, Exp. 05/2021 | 7817 bottles | Class II | — |
| D-0260-2019 | 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; Lot #: JA3077, Exp. 05/2021 | 5100 bottles | Class II | — |
| D-0261-2019 | 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; Lot #: JA9534, Exp. 05/2021 | 1550 bottles | Class II | — |
| D-0262-2019 | 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; Lot #: JA7319, JA 7320, JA7321, Exp. 03/2020 | 23053 bottles | Class III | — |
What to do — step by step
Check Product Details
Look for NDC codes 0185-0122-01 or 0185-0122-10 on the bottle with an expiration date of March 2020.
Questions people ask
Is this product safe to take?
The recall indicates a potential cross-contamination risk, but the product is generally safe if not contaminated. Consult your doctor for specific advice.
How do I know if I have the recalled product?
Check for 100-capsule bottles (NDC 0185-0122-01) or 1000-capsule bottles (NDC 0185-0122-10) with expiration dates of March 2020.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Sandoz Inc. directly for guidance.
Contact Sandoz
We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.
Subject: Recall D-0257-2019 — Sandoz Sandoz Hello, I own a Sandoz that is covered by recall D-0257-2019 from Sandoz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0257-2019 (November 2, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0257-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.