CLASS III ONGOING Drug recall · Reported 7 Jan 2026 · FDA Enforcement Report
traZODONE Hydrochloride Tablets, USP, 100mg recalled
Zydus Pharmaceuticals (USA) is recalling traZODONE Hydrochloride Tablets, USP, 100mg, distributed nationwide in the US. The recall was initiated on 19 Dec 2025 and the FDA has classified it as Class III.
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-0247-2026
- FDA event ID
- 98184
- Recalling firm
- Zydus Pharmaceuticals (USA), Pennington, NJ
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 19 Dec 2025
- FDA classified
- 31 Dec 2025
- Reported
- 7 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Antidepressants
Timeline
| 19 Dec 2025 | Recall initiated by company | |
| 31 Dec 2025 | Classified by FDA | +12 days |
| 7 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Product as listed by the FDA
traZODONE Hydrochloride Tablets, USP, 100mg, 1,000 Tablets, Rx only, Manufactured by: Zydus Lifesciences Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 68382-806-10
Where it was distributed
Nationwide in the USA
Questions about this recall
Is traZODONE Hydrochloride Tablets, USP, 100mg recalled?
Yes. Zydus Pharmaceuticals (USA) recalled traZODONE Hydrochloride Tablets, USP, 100mg on 19 Dec 2025. The recall is Class III and its status is Ongoing. Recall number D-0247-2026.
Why was it recalled?
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Which lots are affected?
Lot # EA00237A, Exp Date: 04/30/2027
Where was it sold?
Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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 Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
| Drug | CLASS II | Trazodone Hydrochloride, USP, 50 mg recalled by Granules PharmaceuticalsTrazodone Hydrochloride | Granules 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 |