CLASS II Drug recall · Reported 29 Jan 2020 · FDA Enforcement Report
Nizatidine Capsules, USP 300 mg recalled by Mylan Pharmaceuticals
Mylan Pharmaceuticals is recalling Nizatidine Capsules, USP 300 mg, distributed nationwide in the US. The recall was initiated on 7 Jan 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-0792-2020
- FDA event ID
- 84607
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jan 2020
- FDA classified
- 20 Jan 2020
- Reported
- 29 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
Timeline
| 7 Jan 2020 | Recall initiated by company | |
| 20 Jan 2020 | Classified by FDA | +13 days |
| 29 Jan 2020 | Published in enforcement report | +9 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: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
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 Capsules, USP 300 mg, Rx Only, Mylan Pharmaceuticals Inc., NDC 0378-5300-93.
Where it was distributed
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
Questions about this recall
Is Nizatidine Capsules, USP 300 mg recalled?
Yes. Mylan Pharmaceuticals recalled Nizatidine Capsules, USP 300 mg on 7 Jan 2020. The recall is Class II and its status is Terminated. Recall number D-0792-2020.
Why was it recalled?
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Which lots are affected?
Lot # 3082876, exp. date January 2020 Lot # 3082877, exp. date January 2020
Where was it sold?
Product was distributed to wholesalers, distributors , retail pharmacies, charitable organizations and mail order pharmacies throughout the United States and the product may have been further distributed.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Nizatidine recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nizatidine Oral Solution, 15 mg/mL (75 mg recalledNizatidine | Amneal Pharmaceuticals of New York | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Nizatidine Capsules, USP 150 mg recalled by Mylan Pharmaceuticals | Mylan Pharmaceuticals | Nitrosamine Impurity | Nationwide |