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Class II · ModerateActive recall

Trazodone Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot: 1394026, Exp. 02/2028.
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Foreign Tablets/Capsules

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTeva Pharmaceuticals USA, Inc.
Brand nameTRAZODONE HYDROCHLORIDE
Generic nameTRAZODONE HYDROCHLORIDE
Active ingredient(s)TRAZODONE HYDROCHLORIDE
Distributed by / forTeva Pharmaceuticals, Parsippany, NJ 07054
NDC50111-560-01
Show the full FDA record
Full product labeltraZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
Recalling firmTeva Pharmaceuticals USA, Inc
DistributionU.S. Nationwide
Quantity175,392 bottles
Recall initiated2026-08-24
Report date2026-09-09
Recall completed—
Recall numberD-0834-2026
ClassificationClass II
FDA statusOngoing
Origin on fileParsippany NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.