Class II · ModerateActive recall
Amlodipine
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberBatch: BBY4D004, BBY4E001, BBY4D001, BBY4D002, BBY4D003
Where it was soldNationwide USA
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: Carcinogen impurity detected in API used to manufacture drug 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
Made byTorrent Pharmaceuticals LTD., Indrad-382 721, India foreign manufacturer
| Distributed by / for | Torrent Pharma Inc. |
| NDC | 13668-329-30 |
Show the full FDA record
| Full product label | Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/25 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-329-30 |
| Recalling firm | Torrent Pharma Inc. |
| Distribution | Nationwide USA |
| Quantity | 37704 bottles |
| Recall initiated | 2018-08-17 |
| Report date | 2018-09-05 |
| Recall completed | — |
| Recall number | D-1145-2018 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Basking Ridge 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.