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Unrated Drug recall · FDA · Published August 24, 2026

Teva recalls traZODone 50mg tablets with foreign tablets risk

Teva Pharmaceuticals recalls 50mg traZODone tablets manufactured in Croatia due to foreign tablets present. Consumers should contact Teva for details.

🇺🇸 FDA recall #D-0834-2026DrugTeva ›
✎ GovInfoNow plain-language explainer

Teva Pharmaceuticals is recalling 50mg traZOD: 100-tablet packages made in Croatia. The recall is due to foreign tablets being present, which could cause harm if taken. Read more at govinfonow.com/recall/838277-teva-recalls-trazodone-50mg-tablets-with-foreign-tablets-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/838277-teva-recalls-trazodone-50mg-tablets-with-foreign-tablets-risk · Updated September 16, 2026 · FDA enforcement record: FDA #D-0834-2026

Cite this page

“Teva recalls traZODone 50mg tablets with foreign tablets risk.” GovInfoNow, updated September 16, 2026. https://govinfonow.com/recall/838277-teva-recalls-trazodone-50mg-tablets-with-foreign-tablets-risk. Based on FDA recall #D-0834-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0834-2026%22&limit=1).

The FDA announced on 2026-08-24 that Teva Pharmaceuticals USA, Inc. is recalling TraZODone Hydrochloride Tablets, USP, 50 mg due to the presence of foreign tablets or capsules. The recall affects 175,392 bottles distributed nationwide.

How to tell if you have it

  • Brand: Teva
  • Product: TraZODone Hydrochloride Tablets, USP, 50 mg
  • NDC: 50111-560-01
  • Lot Code: 1394026
  • Expiration Date: 02/2028
  • Quantity: 175,392 bottles

The hazard

The recall is due to the presence of foreign tablets or capsules in the product. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Teva Pharmaceuticals USA, Inc. has 59 other recalls on record since 2012-04-02. Recent Teva recalls include Octreotide Acetate 30mg Kit (2026-04-24), Claravis 10mg (2026-04-06), and Clonidine Transdermal System (2026-03-19). Other recent recalls of similar products include Granules Pharmaceuticals Trazodone 50mg Recall (2026-01-26), Annora Pharma Pitavastatin Tablets 2mg Recall (2026-02-03), and Bionpharma Divalproex Tablets Recall (2026-06-26).

How to tell if you have this one

Check for the NDC code 50111-560-01 on the packaging. The product was manufactured in Croatia by Pliva Hrvatska d.o.o, Zagreb, and expires February 2028.

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

What to do — step by step

  1. Contact Teva

    Reach out to Teva Pharmaceuticals for specific instructions on how to handle the recalled product.

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

Distributed nationwide.

Recall timeline

FDA published this recall 16 days after the firm started it.

1. Firm started the recall: Aug 24, 202612. FDA classified it Class II: Sep 8, 202623. Published in FDA’s Enforcement Report: Sep 9, 202634. Added to GovInfoNow: Sep 15, 202642026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. Added to GovInfoNow

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

Similar recalls

Other Teva recalls

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-0834-2026 (August 24, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0834-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on September 16, 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