US Drug Recall Register
Class III · Low risk Terminated Initiated Apr 6, 2018 (8 years ago)

Triamterene and Hydrochlorothiazide Tablets

Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.

Why it was recalled

Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).

What was recalled

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
NDC code
0781-5067-05
Origin
CO, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0631-2018

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Hydrochlorothiazide recalls

See all
Class II · Moderate risk Ongoing

Bisoprolol Fumarate and Hydrochlorothiazide tablets

Reason cGMP Deviations: recall due to not meeting the N-Nitroso Bisoprolol impurity specification limits.

Unichem Pharmaceuticals USA Inc. NDC 29300-187-01 D-0301-2026
Class III · Low risk Ongoing

Bisoprolol Fumarate and Hydrochlorothiazide Tablets

Reason Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

Glenmark Pharmaceuticals Inc., USA D-0199-2026
Class II · Moderate risk Ongoing

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg

Reason Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

Lupin Pharmaceuticals Inc. NDC 68180-519-01 D-0532-2025