Class III · Lower riskRecall completed
Triamterene and Hydrochlorothiazide Tablets
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot #: GW8264, HD3095, Exp 12/18
Where it was soldNationwide in the USA and Puerto Rico
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
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
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
| Distributed by / for | Sandoz Incorporated |
| NDC | 0781-5067-05 |
Show the full FDA record
| Full product label | Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc., Princeton, NJ 08540, NDC 0781-5067-05. |
| Recalling firm | Sandoz Incorporated |
| Distribution | Nationwide in the USA and Puerto Rico |
| Quantity | 11,680 bottles |
| Recall initiated | 2018-04-06 |
| Report date | 2018-04-25 |
| Recall completed | 2019-04-08 |
| Recall number | D-0631-2018 |
| Classification | Class III |
| FDA status | Terminated |
| Origin on file | Broomfield CO 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.