CLASS III Drug recall · Reported 25 Apr 2018 · FDA Enforcement Report
Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg recalled
Sandoz is recalling Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, distributed nationwide in the US. The recall was initiated on 6 Apr 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0631-2018
- FDA event ID
- 79788
- Recalling firm
- Sandoz, Broomfield, CO
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 6 Apr 2018
- FDA classified
- 16 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Pressure Medication
Timeline
| 6 Apr 2018 | Recall initiated by company | |
| 16 Apr 2018 | Classified by FDA | +10 days |
| 25 Apr 2018 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the USA and Puerto Rico
Questions about this recall
Why was it recalled?
Cross Contamination With Other Products: presence of unrelated ingredients (i.e. traces of Lisinopril, Mannitol, Iron, Calcium and Phosphorous).
Which lots are affected?
Lot #: GW8264, HD3095, Exp 12/18
Where was it sold?
Nationwide in the USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Triamterene recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg recalled | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg) recalled | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS III | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg) recalled | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS III | Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg recalled | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Triamterene/ Hydrochlorothiazide, Tablet, 37.5 mg/25 mg recalled | Aidapak Services | Labeling Errors | 4 states |