CLASS II ONGOING Drug recall · Reported 8 Jan 2020 · FDA Enforcement Report
Ranitidine Tablets, USP 150mg, Country of Origin: India recalled
Granules India is recalling Ranitidine Tablets, USP 150mg, Country of Origin: India, distributed in New Jersey, New York, Oregon. The recall was initiated on 13 Dec 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-0632-2020
- FDA event ID
- 84522
- Recalling firm
- Granules India, Qutbullapur Mandal, Ranga Redd, N/A
- Brand
- Ranitidine
- Manufacturer
- Granules India Ltd
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Dec 2019
- FDA classified
- 29 Dec 2019
- Reported
- 8 Jan 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 13 Dec 2019 | Recall initiated by company | |
| 29 Dec 2019 | Classified by FDA | +16 days |
| 8 Jan 2020 | 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: Impurity N-nitrosodimethylamine (NDMA) found in API
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
RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32
Where it was distributed
OR, NY, NJ
Questions about this recall
Why was it recalled?
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Which lots are affected?
7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
Where was it sold?
OR, NY, NJ
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 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 |