Class II · ModerateRecall completed
Ranitidine Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot #: I2519H, Exp. 12/20; I2719O, Exp. 12/20; J1419O, Exp. 12/20; J2819L, Exp. 12/20
Where it was soldCA, FL
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 | Preferred Pharmaceuticals, Inc |
| NDC | 68788-7078-03 |
Show the full FDA record
| Full product label | Ranitidine Tablets, USP 150 mg, OTC, a.) 30 count bottle (NDC 68788-7078-03), b.) 60 count bottle (NDC 68788-7078-06), Mfg: Amneal Pharmaceuticals |
| Recalling firm | Preferred Pharmaceuticals, Inc |
| Distribution | CA, FL |
| Quantity | 316 bottles |
| Recall initiated | 2019-12-02 |
| Report date | 2019-12-18 |
| Recall completed | 2023-05-09 |
| Recall number | D-0617-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Anaheim CA 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.