Class II · ModerateRecall completed
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot # B0438903-052118 [redacted-phone]
Where it was soldProduct was distributed to a medical facility in South Carolina
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 trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
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 | RemedyRepack Inc. |
| NDC | 13668-0325-30 |
Show the full FDA record
| Full product label | Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00 |
| Recalling firm | RemedyRepack Inc. |
| Distribution | Product was distributed to a medical facility in South Carolina |
| Quantity | 2 bottles of 90 tablets (180 tablets) |
| Recall initiated | 2018-08-24 |
| Report date | 2018-10-31 |
| Recall completed | 2018-10-29 |
| Recall number | D-0093-2019 |
| Classification | Class II |
| FDA status | Terminated |
| Origin on file | Indiana PA 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.