Class II · ModerateRecall completed
Ranitidine Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera). N106851901, Exp. 11/30/2021 N106851902, Exp. 10/31/2021 b). C106851901, Exp. 11/30/2021 C106851902 Exp. 10/31/2021 C106851903 Exp. 02/28/2022 C106851904 Exp. 11/30/2021 C106851905 Exp. 05/31/2022
Where it was soldNationwide
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: Presence of NDMA impurity detected in product.
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
| Distributed by / for | Denton Pharma, Inc. |
| NDC | 70934-287-15 |
Show the full FDA record
| Full product label | Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131 |
| Recalling firm | Denton Pharma, Inc. |
| Distribution | Nationwide |
| Quantity | 467 bottles |
| Recall initiated | 2019-12-20 |
| Report date | 2020-01-29 |
| Recall completed | 2023-10-05 |
| Recall number | D-0795-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | North Blenheim NY United States |
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.