CLASS III Drug recall · Reported 25 Jan 2023 · FDA Enforcement Report
Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg) recalled
Lannett is recalling Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), distributed nationwide in the US. The recall was initiated on 9 Nov 2022 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-0161-2023
- FDA event ID
- 91142
- Recalling firm
- Lannett, Seymour, IN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Nov 2022
- FDA classified
- 16 Jan 2023
- Reported
- 25 Jan 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 9 Nov 2022 | Recall initiated by company | |
| 16 Jan 2023 | Classified by FDA | +68 days |
| 25 Jan 2023 | 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
Failed Impurity/Degradation Specifications
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 Capsules, USP (37.5 mg/25 mg), Rx Only, [100 or 1000 ] Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC 100 Count bottle: 0527-1632-01; NDC 1,000 bottle: 0527-1632-10
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specifications
Which lots are affected?
Lots: 21000279A (exp 01/2023), 20256320A (12/2022)
Where was it sold?
Nationwide USA
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.
Other products in this recall event
1 other product · FDA event 91142| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg) recalled | Lannett | Potency & Assay | Nationwide |
More recalls from Lannett
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Packaging Defects | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS III | Primidone Tablets USP, 250mg recalled by Lannett CompanyPrimidone | Lannett | Other | Nationwide |
| Drug | CLASS II | Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate | Lannett | Other | OH |
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 Tablets, USP 37.5 mg/25 mg recalled | Mylan Pharmaceuticals | 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 |