Trazodone Hydrochloride recall
FDA recall D-0305-2026 · initiated Jan 26, 2026
Granules Pharmaceuticals Inc. recalled Trazodone Hydrochloride in Jan 2026 — an FDA Class II recall (D-0305-2026) because Presence of Foreign Tablets/Capsules.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Presence of Foreign Tablets/Capsules
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
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: 71424 bottles.
Details
- Product
- 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.
- Recalling company
- Granules Pharmaceuticals Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- US Nationwide.
- Initiated
- Jan 26, 2026
- FDA report date
- Feb 11, 2026
Frequently asked
- Was Trazodone Hydrochloride recalled?
- Granules Pharmaceuticals Inc. recalled Trazodone Hydrochloride in Jan 2026 — an FDA Class II recall (D-0305-2026) because Presence of Foreign Tablets/Capsules. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Trazodone Hydrochloride recalled?
- Per the FDA enforcement record, the reason for recall D-0305-2026 was: Presence of Foreign Tablets/Capsules
- Is a recalled Trazodone Hydrochloride 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. May cause temporary or medically reversible harm; low probability of serious harm. 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 are affected?
- Distributed: US Nationwide.. The recall covers these lots — Batch # 6160008A, Exp Date: 12/31/2026. 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-0305-2026.