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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # EA00237A, Exp Date: 04/30/2027
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0247-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Dec 19, 2025
- FDA report date
- Jan 7, 2026
- Quantity
- 2,136 1000-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
Original FDA data
Every field from FDA enforcement report D-0247-2026, exactly as published.
Show all FDA fields
- City
- Pennington
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98184
- Address
- 73 Route 31 N
- Code information
- Lot # EA00237A, Exp Date: 04/30/2027
- Postal code
- 08534-3601
- Report date
- Jan 7, 2026
- Product type
- Drugs
- Recall number
- D-0247-2026
- Classification
- Class III
- Recalling firm
- Zydus Pharmaceuticals (USA) Inc
- Product quantity
- 2,136 1000-count bottles
- Reason for recall
- Failed Tablet/Capsule Specifications: Product complaint received that some tablets had a dent on the plain side of the tablet surface.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Dec 19, 2025
- Initial firm notification
- Letter
- Center classification date
- Dec 31, 2025