FDA Drug recall D-0834-2026
traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manuf…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-09
On 2026-09-09 the FDA classified a Class II recall of traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manuf… by Teva Pharmaceuticals Usa, citing presence of Foreign Tablets/Capsules.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0834-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-24 |
| Published | 2026-09-09 |
| Last updated | 2026-09-15 05:30 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
Product
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
Reason
Presence of Foreign Tablets/Capsules
Identifiers
| ndc | 50111-560-01 |
|---|---|
| ndc | 50111-560-02 |
| ndc | 50111-560-03 |
| ndc | 50111-561-01 |
| ndc | 50111-561-02 |
| ndc | 50111-561-03 |
| ndc | 50111-450-01 |
| ndc | 50111-450-02 |
| code_info | Lot: 1394026, Exp. 02/2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-15 05:30 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-04-15 · Teva Pharmaceuticals Usa
All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0834-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.