Class II · ModerateActive recall
Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL)
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot number06648001A 11/2019 06648003A 4/2020 06649001A 1/2021
Where it was soldProduct was distributed throughout the United States.
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
| Distributed by / for | Amneal Pharmaceuticals, Inc. |
| NDC | 65162-664-90 |
Show the full FDA record
| Full product label | Ranitidine Syrup Oral Solution 15 mg/mL 6. fl. oz. (473 mL), NDC 65162-664-90. |
| Recalling firm | Amneal Pharmaceuticals, Inc. |
| Distribution | Product was distributed throughout the United States. |
| Quantity | N/A |
| Recall initiated | 2019-11-22 |
| Report date | 2019-12-18 |
| Recall completed | — |
| Recall number | D-0614-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Brookhaven 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.