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Drug FDA Class II Ongoing Foreign material

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.

Granules Pharmaceuticals Inc. Published Feb 11, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Granules Pharmaceuticals Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Presence of Foreign Tablets/Capsules

Hazards

Foreign Tablets/Capsules · primary

Affected products (1)

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.

TRAZODONE HYDROCHLORIDE · 71424 bottles.

NDC: 70010-231, 70010-232, 70010-233, 70010-234, 70010-231-03, 70010-231-01, 70010-231-05, 70010-231-10, 70010-232-03, 70010-232-01, 70010-232-05, 70010-232-10, 70010-233-03, 70010-233-01, 70010-233-05, 70010-234-03, 70010-234-01, 70010-234-05
Code info: Batch # 6160008A, Exp Date: 12/31/2026

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 26, 2026
  2. Published
    Feb 11, 2026
Recall number
D-0305-2026
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.