Amneal Pharmaceuticals of New York, LLC recalls Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC
Amneal recalls Nizatidine Oral Solution bottles with potential N-Nitrosodimethylamine (NDMA) levels above FDA limits. This medication is prescription-only and distributed by Gemini Laboratories.
Lower-risk recall
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Contact the company & request your remedy
What happened, in plain English
Amneal Pharmaceuticals is recalling prescription Nizatidine Oral Solution bottles due to potential levels of N-Nitrosodimethylamine (NDMA) exceeding FDA safety limits. This risk could affect users of this medication, which is sold in 480mL bottles with specific NDC numbers. Read more at govinfonow.com/recall/37142-amneal-nizatidine-oral-solution-recall-potential-ndma-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37142-amneal-nizatidine-oral-solution-recall-potential-ndma-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1253-2020
Cite this page
“Amneal Nizatidine Oral Solution Recall: Potential NDMA Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37142-amneal-nizatidine-oral-solution-recall-potential-ndma-risk. Based on FDA recall #D-1253-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1253-2020%22&limit=1).
Why it’s dangerous
The recall is due to potential N-Nitrosodimethylamine (NDMA) levels in the medication that could exceed FDA safety limits. NDMA is a chemical that has been linked to health risks, though the specific risk level in this product is not detailed in the recall.
Who’s affected
Prescription users of Nizatidine Oral Solution who received bottles with the specified NDC numbers. Those with the medication in their possession are most at risk.
How to tell if you have this one
Check for NDC numbers 60846-301-15, 06598004A, 06599001A, or 06599002A on the bottle label. The product was distributed by Gemini Laboratories, LLC in New Jersey starting in April 2020 and December 2020.
- Brand
Amneal- Category
Drug
What to do — step by step
Check Product Label
Look for NDC numbers 60846-301-15, 06598004A, 06599001A, or 06599002A on the bottle.
Questions people ask
Is this medication safe to use?
The recall states potential NDMA levels above FDA limits, but the exact risk level is not specified. Consult your healthcare provider for advice.
What should I do if I have this medication?
The recall does not specify a remedy, so contact Amneal Pharmaceuticals or your healthcare provider for guidance.
When was this product distributed?
The product was distributed by Gemini Laboratories, LLC starting in April 2020 and December 2020.
Contact Amneal
We’ve drafted a message you can send Amneal to request your refund or repair — edit it as you like.
Subject: Recall D-1253-2020 — Amneal Amneal Hello, I own a Amneal that is covered by recall D-1253-2020 from Amneal. 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-1253-2020 (April 15, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1253-2020 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.