Class II · ModerateRecall completed
Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberHD8625 4/30/2020 HD9275 4/30/2020 HU2207 8/31/2020 HX6676 3/31/2021 HX6677 3/31/2021
Where it was soldU.S. Nationwide
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: Detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA).
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 bySandoz Inc. Princeton, NJ 08540 Product of India foreign manufacturer
| Distributed by / for | Sandoz, Inc |
| NDC | 0781-2865-31 |
Show the full FDA record
| Full product label | Sandoz Ranitidine Hydrochloride Capsules 300mg 30 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ 08540 Product of India NDC 0781-2865-31 |
| Recalling firm | Sandoz, Inc |
| Distribution | U.S. Nationwide |
| Quantity | 136,788 bottles |
| Recall initiated | 2019-09-23 |
| Report date | 2019-10-16 |
| Recall completed | 2023-07-14 |
| Recall number | D-0129-2020 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Princeton NJ 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.