traZODONE Hydrochloride Tablets recall
FDA recall D-0247-2026 · initiated Dec 19, 2025
Zydus Pharmaceuticals (USA) Inc recalled traZODONE Hydrochloride Tablets in Dec 2025 — an FDA Class III recall (D-0247-2026) because Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 2,136 1000-count bottles
Details
- Product
- 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
- Recalling company
- Zydus Pharms
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Dec 19, 2025
- FDA report date
- Jan 7, 2026
Frequently asked
- Was traZODONE Hydrochloride Tablets recalled?
- Zydus Pharmaceuticals (USA) Inc recalled traZODONE Hydrochloride Tablets in Dec 2025 — an FDA Class III recall (D-0247-2026) because Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was traZODONE Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0247-2026 was: Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
- Is a recalled traZODONE Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of traZODONE Hydrochloride Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot # EA00237A, Exp Date: 04/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0247-2026.