CLASS III Drug recall · Reported 18 Jul 2018 · FDA Enforcement Report
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg recalled
Mylan Pharmaceuticals is recalling Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, distributed nationwide in the US. The recall was initiated on 9 Jul 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-0978-2018
- FDA event ID
- 80454
- Recalling firm
- Mylan Pharmaceuticals, Morgantown, WV
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Jul 2018
- FDA classified
- 24 Jul 2018
- Reported
- 18 Jul 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 9 Jul 2018 | Recall initiated by company | |
| 18 Jul 2018 | Published in enforcement report | +9 days |
| 24 Jul 2018 | Classified by FDA | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 2007979, Exp. 11/30/2020
Where was it sold?
Nationwide within the United States
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.
More recalls from Mylan Pharmaceuticals
All 84| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Prasugrel Tablets, USP, 10mg recalled by Mylan PharmaceuticalsPrasugrel | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Carton label: Mycophenolate Mofetil for injection recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Acamprosate Calcium, Delayed-Release Tablets, 333 mg recalledAcamprosate Calcium | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mycophenolate Mofetil for Injection USP, 500 mg/Vial recalledMycophenolate Mofetil | Mylan Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Amnesteem (Isotretinoin) Capsules, USP 40 mg recalledAmnesteem | Mylan Pharmaceuticals | Potency & Assay | Nationwide |
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, 75 mg/50 mg recalled | Sandoz | Other | Nationwide |
| Drug | CLASS II | Triamterene/ Hydrochlorothiazide, Tablet, 37.5 mg/25 mg recalled | Aidapak Services | Labeling Errors | 4 states |