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Lower risk Drug recall · FDA · Published June 28, 2024

Teva Fludrocortisone Tablets Recall: Impurities May Pose Health Risk

Teva Pharmaceuticals recalls 0.1mg fludrocortisone tablets due to impurities exceeding safety limits. Affected lots manufactured in Canada expire 2024. Consumers should check NDC 0555-0997-02 for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0601-2024DrugTeva ›
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Contact the company

Recalling firmTeva Pharmaceuticals USA, Inc400 Interpace Pkwy Bldg A · Parsippany, NJ 07054-1120
✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals is recalling fludrocortisone acetate tablets (0.1mg) because impurities in the product exceed safe levels. This could pose health risks to people using the medication as prescribed. Read more at govinfonow.com/recall/32600-teva-fludrocortisone-tablets-recall-impurities-may-pose-health-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/32600-teva-fludrocortisone-tablets-recall-impurities-may-pose-health-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0601-2024

Cite this page

“Teva Fludrocortisone Tablets Recall: Impurities May Pose Health Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32600-teva-fludrocortisone-tablets-recall-impurities-may-pose-health-risk. Based on FDA recall #D-0601-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0601-2024%22&limit=1).

The FDA announced on June 28, 2024, that Teva Pharmaceuticals USA, Inc. is recalling Fludrocortisone Acetate Tablets due to failed impurity specifications. Owners should contact the company for a refund.

How to tell if you have it

  • Brand: Teva
  • Product: Fludrocortisone Acetate Tablets, USP 0.1mg, Rx Only, 100 Tablets per bottle
  • NDC: 0555-0997-02
  • Lot codes: CNSDH (Exp. 6/30/2024); CNWVM, CNWWH (Exp. 07/31/2024); CNXKW, CNXKY, CNXMB, CNXMH (Exp. 09/30/2024); CPBTP, CPBTV (Exp. 11/30/2024)
  • Quantity: 116,144 bottles
  • Distribution: Nationwide in the USA and Puerto Rico

The hazard

The product is being recalled because API related substances and unknown impurities exceed specification limits.

Context

GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has had 59 other recalls on record since April 2, 2012. Other recent recalls of similar products include a recall of traZODone 50mg tablets with foreign tablets risk (Aug. 24, 2026), Octreotide Acetate 30mg Kit sterility risk (April 24, 2026), and Claravis 10mg due to impurity issues (April 6, 2026). Other recent recalls of similar products include Sun Pharmaceutical Fexofenadine 180mg Tablets recall for impurities risk (June 1, 2026), Sun Pharmaceutical Fluocinolone Acetonide Solution recall for impurity risk (Dec. 30, 2025), and Somerset Therapeutics Dexamethasone Injection recall where impurities may cause harm (Feb. 4, 2026).

How to tell if you have this one

Check for the NDC code 0555-0997-02 on the product label. The product was manufactured in Canada with specific lot numbers: CNSDH, CNWVM, CNWWH, CNXKW, CNXKY, CNXMB, CNXMH, CPBTP, CPBTV, expiring between June 2024 and November 2024.

  • Brand
    Teva
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the NDC code 0555-0997-02 on the tablet packaging.

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: yesFLPuerto Rico: yesPR

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

Distributed nationwide.

Recall timeline

FDA published this recall 26 days after the firm started it.

1. Firm started the recall: Jun 28, 202412. FDA classified it Class II: Jul 16, 202423. Published in FDA’s Enforcement Report: Jul 24, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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

Similar recalls

American Health Packaging Recalls Metoclopramide Tablets Due to Foreign Drug Presence
American Health PackagingTeva Recalls Metoclopramide Tablets Due to Foreign Contaminants
Teva Pharmaceuticals USA, IncPreferred Pharma Recalls Lidocaine Ointment Due to Content Issues
Preferred Pharmaceuticals, Inc.Northstar Rx Recalls Tretinoin Cream Due to Impurities
SUN PHARMACEUTICAL INDUSTRIES INCApothecary Pharma Recalls Tirzepatide Injections Due to Sterility Risk
Apothecary Pharma LLC

Other Teva recalls

Teva Pharmaceuticals USA, Inc recalls traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o,
August 24, 2026Teva Pharmaceuticals USA, Inc recalls Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, In Single-Dose kits containing:
April 24, 2026Teva Pharmaceuticals USA, Inc recalls Claravis (isotretinoin capsule, USP), 10 mg, Packaged as a) 100-count carton, NDC 0555-1054-56, with 10x10 blister
April 6, 2026Teva Pharmaceuticals USA, Inc recalls Clonidine Transdermal System, USP, 0.2 mg/day, supplied in cartons of 4 Systems and 4 Adhesive Covers, Rx only,
March 19, 2026Teva Pharmaceuticals USA, Inc recalls Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles
January 29, 2026Teva Pharmaceuticals USA, Inc recalls Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA,
January 12, 2026

Keep exploring

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-0601-2024 (June 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0601-2024 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 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