Why it was recalled
Presence of Foreign Tablets/Capsules
Product description
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
Lot numbers, UPCs & expiration codes
Batch # 6160008A, Exp Date: 12/31/2026
Where it was sold
US Nationwide.
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-0305-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 26, 2026
- FDA report date
- Feb 11, 2026
- Quantity
- 71424 bottles.
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Granules Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0305-2026, exactly as published.
Show all FDA fields
- City
- Chantilly
- State
- VA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98345
- Address
- 3701 Concorde Pkwy
- Code information
- Batch # 6160008A, Exp Date: 12/31/2026
- Postal code
- 20151-1126
- Report date
- Feb 11, 2026
- Product type
- Drugs
- Recall number
- D-0305-2026
- Classification
- Class II
- Recalling firm
- Granules Pharmaceuticals Inc.
- Product quantity
- 71424 bottles.
- Reason for recall
- Presence of Foreign Tablets/Capsules
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only, Manufactured by: Granules India Limited, Hyderabad, 500 081, India, Manufactured for: Granules Pharmaceuticals Inc., Chantilly, VA 20151, NDC 70010-231-01.
- Distribution pattern
- US Nationwide.
- Recall initiation date
- Jan 26, 2026
- Center classification date
- Feb 11, 2026