FDAClass IIRecall started August 24, 2026

traZODone Hydrochloride Tablets 50 mg Recall

traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured…

What is the FDA recall status?

The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.

How FDA enforcement data reports status

Why was traZODone Hydrochloride Tablets 50 mg recalled?

Presence of Foreign Tablets/Capsules

What should I do if I have this product?

Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.

Full product description

traZODone 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

Which lot codes, UPCs or models are affected?

Lot: 1394026, Exp. 02/2028.

Agency record number
D-0834-2026
Product
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured…
Recalling firm
Teva Pharmaceuticals USA, Inc
Quantity
175,392 bottles
Distribution
U.S. Nationwide
Recall started
August 24, 2026
Report date
September 9, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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