CLASS II ONGOING Drug recall · Reported 9 Sep 2026 · FDA Enforcement Report
traZODone Hydrochloride Tablets, USP, 50 mg recalled
Teva Pharmaceuticals USA is recalling traZODone Hydrochloride Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 24 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0834-2026
- FDA event ID
- 99734
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Manufacturer
- Teva Pharmaceuticals USA, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Aug 2026
- FDA classified
- 8 Sep 2026
- Reported
- 9 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 24 Aug 2026 | Recall initiated by company | |
| 8 Sep 2026 | Classified by FDA | +15 days |
| 9 Sep 2026 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules
Which lots are affected?
Lot: 1394026, Exp. 02/2028.
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Trazodone recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride | Granules Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | traZODONE Hydrochloride Tablets, USP, 100mg recalledTrazodone Hydrochloride | Zydus Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Trazodone Hydrochloride Tablets, USP 50mg 10x10ud recalledTrazodone Hydrochloride | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS I | TraZODONE Hydrochloride Tablets USP 100 mg recalled by AVKARE | Avkare | Hidden Drug Ingredients | Nationwide |
| Drug | CLASS II | traZODone HCl Tablet, 150 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |