CLASS II Drug recall · Reported 6 May 2020 · FDA Enforcement Report
Nizatidine Oral Solution, 15 mg/mL (75 mg recalled
Amneal Pharmaceuticals of New York is recalling Nizatidine Oral Solution, 15 mg/mL (75 mg/ USP, distributed nationwide in the US. The recall was initiated on 15 Apr 2020 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-1253-2020
- FDA event ID
- 85386
- Recalling firm
- Amneal Pharmaceuticals of New York, Brookhaven, NY
- Brand
- Nizatidine
- Manufacturer
- Amneal Pharmaceuticals LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Apr 2020
- FDA classified
- 24 Apr 2020
- Reported
- 6 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Nitrosamine Impurity
Timeline
| 15 Apr 2020 | Recall initiated by company | |
| 24 Apr 2020 | Classified by FDA | +9 days |
| 6 May 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Which lots are affected?
06598004A 04/2020 06599001A 12/2020 06599002A 12/2020
Where was it sold?
Nationwide
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.
More recalls from Amneal Pharmaceuticals of New York
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Exenatide Injection, USP, 250 mcg/mL per prefilled pen recalledExenatide | Amneal Pharmaceuticals of New York | Other | Nationwide |
| Drug | CLASS II | Methylergonovine Maleate Tablets, USP, 0.2mg recalledMethylergonovine Maleate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS I | Vancomycin Hydrochloride for Oral Solution, USP, 250 mg recalledVancomycin Hydrochloride | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Divalproex Sodium Extended-release Tablets, USP 250 mg recalledDivalproex Sodium | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
| Drug | CLASS II | Oseltamivir Phosphate for Oral Suspension 6mg/ml (reconstituted) recalledOseltamivir Phosphate | Amneal Pharmaceuticals of New York | Potency & Assay | Nationwide |
Other Nizatidine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nizatidine Capsules, USP 300 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Nizatidine Capsules, USP 150 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Nitrosamine Impurity | Nationwide |