Class II · ModerateActive recall
Ranitidine
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number7730001A, 7730002A, 7730003A, 7730004A, 7730005A, 7730006A, 7730007A, 7730008A, 7730009A, 7730010A, 7730011A and 7730012A
Where it was soldOR, NY, NJ
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byGranules India Ltd
| Brand name | RANITIDINE |
| Generic name | RANITIDINE |
| Active ingredient(s) | RANITIDINE HYDROCHLORIDE |
| Distributed by / for | Granules India Limited |
| NDC | 62207-773-32 |
Show the full FDA record
| Full product label | RANITIDINE TABLETS, USP 150mg, 10,000-count bag, Country of Origin: INDIA NDC 62207-773-32 |
| Recalling firm | Granules India Limited |
| Distribution | OR, NY, NJ |
| Quantity | 23,090,000 tablets |
| Recall initiated | 2019-12-13 |
| Report date | 2020-01-08 |
| Recall completed | — |
| Recall number | D-0632-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Qutbullapur Mandal, Ranga Redd N/A India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.