CLASS II Drug recall · Reported 20 Nov 2019 · FDA Enforcement Report
Ranitidine Capsules 150 mg recalled by Novitium Pharma
Novitium Pharma is recalling Ranitidine Capsules 150 mg, distributed nationwide in the US. The recall was initiated on 25 Oct 2019 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-0310-2020
- FDA event ID
- 84147
- Recalling firm
- Novitium Pharma, East Windsor, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Oct 2019
- FDA classified
- 10 Nov 2019
- Reported
- 20 Nov 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 25 Oct 2019 | Recall initiated by company | |
| 10 Nov 2019 | Classified by FDA | +16 days |
| 20 Nov 2019 | Published in enforcement report | +10 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: Presence of NDMA impurity detected in product.
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
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
all lots within expiry.
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.
Other products in this recall event
3 other products · FDA event 84147This product is part of a recall event; the main page for the event is Ranitidine Capsules 150 mg recalled by Novitium Pharma.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ranitidine Capsules 150 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide | |
| CLASS II | Ranitidine Capsules 300 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide | |
| CLASS II | Ranitidine Capsules 300 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
More recalls from Novitium Pharma
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Digoxin Tablets, USP 62.5 mcg (0.0625 mg) recalled by Novitium PharmaDigoxin | Novitium Pharma | Potency & Assay | Nationwide |
| Drug | CLASS III | Digoxin Tablets, USP 125mcg, (0.125 mg) recalled by Novitium PharmaDigoxin | Novitium Pharma | Other | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 300 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 300 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Capsules 150 mg recalled by Novitium Pharma | Novitium Pharma | Nitrosamine Impurity | Nationwide |
Other Ranitidine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine 300 mg, 30 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled | American Health Packaging | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | ranitidine hydrochloride, USP a) bottles recalled | PD-Rx Pharmaceuticals | Nitrosamine Impurity | 12 states |