Sandoz Triamterene and Hydrochlorothiazide Tablets Recall

Why it was recalled

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

Product description

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.

Lot numbers, UPCs & expiration codes

Lot #: GW8264, HD3095, Exp 12/18

Where it was sold

Nationwide in the USA and Puerto Rico

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0631-2018
Classification: Class III
Status: Terminated
Recall initiated: Apr 6, 2018
FDA report date: Apr 25, 2018
Quantity: 11,680 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Sandoz Incorporated

Original FDA data

Every field from FDA enforcement report D-0631-2018, exactly as published.

Show all FDA fields

City: Broomfield
State: CO
Status: Terminated
Country: United States
Event ID: 79788
Address: 2555 W Midway Blvd
Code information: Lot #: GW8264, HD3095, Exp 12/18
Postal code: 80020-1632
Report date: Apr 25, 2018
Product type: Drugs
Recall number: D-0631-2018
Classification: Class III
Recalling firm: Sandoz Incorporated
Product quantity: 11,680 bottles
Termination date: Apr 8, 2019
Reason for recall: Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Voluntary / mandated: Voluntary: Firm initiated
Product description: 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.
Distribution pattern: Nationwide in the USA and Puerto Rico
Recall initiation date: Apr 6, 2018
Initial firm notification: Letter
Center classification date: Apr 16, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0631-2018, published Apr 25, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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