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Unrated Drug recall · FDA · Published November 9, 2022

Lannett Triamterene/Hydrochlorothiazide Capsules Recall: Failed Impurity Specifications

Lannett recalls triamterene and hydrochlorothiazide capsules (37.5 mg/25 mg) due to failed impurity and degradation specifications. Rx-only capsules with NDC 0527-1632-01 or 0527-1632-10 lots 21000279A (exp 01/2023) and 20256320A (12/2022) are affected.

🇺🇸 FDA recall #D-0161-2023DrugLannett ›
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Recalling firmLannett Company Inc.1101 C Ave W · Seymour, IN 47274-3342
✎ GovInfoNow plain-language explainer

Lannett is recalling triamterene and hydrochlorothiazide capsules (37.5 mg/25 mg) that may have failed impurity or degradation specifications. This could pose a risk to users, though the specific danger isn't detailed in the recall notice. Read more at govinfonow.com/recall/34228-lannett-triamterene-hydrochlorothiazide-capsules-recall-failed-impurity-specifications.

Source Summary by GovInfoNow · govinfonow.com/recall/34228-lannett-triamterene-hydrochlorothiazide-capsules-recall-failed-impurity-specifications · Updated August 18, 2026 · FDA enforcement record: FDA #D-0161-2023

Cite this page

“Lannett Triamterene/Hydrochlorothiazide Capsules Recall: Failed Impurity Specifications.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34228-lannett-triamterene-hydrochlorothiazide-capsules-recall-failed-impurity-specifications. Based on FDA recall #D-0161-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0161-2023%22&limit=1).

The FDA announced on November 9, 2022, that Lannett Company Inc. is recalling Triamterene and Hydrochlorothiazide Capsules due to failed impurity specifications. The agency said the recall affects approximately 20,040 bottles distributed nationwide.

How to tell if you have it

  • Brand: Lannett
  • Product: Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg)
  • NDC 100 Count bottle: 0527-1632-01
  • NDC 1,000 bottle: 0527-1632-10
  • Lot 21000279A (exp 01/2023)
  • Lot 20256320A (12/2022)

The hazard

The recall was initiated because the Triamterene and Hydrochlorothiazide Capsules failed impurity or degradation specifications. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Lannett Company Inc. has had 13 other recalls on record since October 11, 2018. Other recent recalls of similar products include Hikma Ramipril Capsules (August 24, 2026), Unichem Bisoprolol/Hydrochlorothiazide Tablets (January 21, 2026), and Asclemed Duloxetine Capsules (May 14, 2026).

How to tell if you have this one

Check for NDC codes 0527-1632-01 (100-count) or 0527-1632-10 (1000-count) bottles. Look for lots 21000279A (expiring 01/2023) or 20256320A (12/2022).

  • Brand
    Lannett
  • Category
    Drug
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class III
  • Status
    Terminated
  • Distribution
    Nationwide USA
Recall numberProduct, codes & lotsQuantity
D-0160-2023Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg), Rx Only, 1000 Capsules per bottle, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136. NDC: 0527-1632-10; Lots: 20256318A (12/2022), 20256321A (12/2022), 21000238A (01/2023)5,640 bottles
D-0161-2023Triamterene 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; Lots: 21000279A (exp 01/2023), 20256320A (12/2022)20,040 bottles
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Identify the NDC code and lot number on the bottle to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

1. Firm started the recall: Nov 9, 202212. FDA classified it Class III: Jan 16, 202323. Published in FDA’s Enforcement Report: Jan 25, 202334. FDA terminated the recall: Jun 8, 2023420222023
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0161-2023 (November 9, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0161-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA