FDA recall, , Moderate risk
Granules Trazodone Hydrochloride Tablets
Trazodone Hydrochloride tablets contain foreign tablets or capsules.
Summary by Recall Canary from the FDA notice
What happened
Granules Pharmaceuticals Inc., of Chantilly, Virginia, recalled Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottles, Rx only, because of the presence of foreign tablets or capsules. The recall, which began on January 26, 2026, was added to the FDA's Enforcement Report on February 5, 2026, and classified by the FDA on February 11, 2026. The product was distributed nationwide in the US.
The recalled bottles were manufactured by Granules India Limited, Hyderabad, 500 081, India, for Granules Pharmaceuticals Inc. The recall covers 71,424 bottles. People who have the product may be affected by the foreign tablets or capsules.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle
- NDC
- 70010-231-01
- Lot code
- 6160008A
Recall details
- Company began the recall
- Sold in
US Nationwide.
- Company
- Granules Pharmaceuticals Inc.Chantilly, Virginia
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98345
- Recall number
- D-0305-2026
- Quantity recalled
- 71424 bottles.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA · In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
