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Verified · FDAClass II — Possible RiskMedications

Trazodone Hydrochloride, USP, 50 mg, 100-Count Bottle, Rx only Recall 2026

TRAZODONE HYDROCHLORIDEIssued January 26, 2026Updated Reviewed by the Recall Watch editorial team

TRAZODONE HYDROCHLORIDE 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 — recalled per FDA on 1/26/2026. Reason: Presence of Foreign Tablets/Capsules.

Agency
FDA
Issued
Jan 26, 2026
Brand
TRAZODONE HYDROCHLORIDE
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued January 26, 2026 · Last synced Nov 1, 2026

What's recalled

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.

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Why it was recalled

Presence of Foreign Tablets/Capsules

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Batch # 6160008A
Exp Date: 12/31/2026
Where was it sold
1 state

US Nationwide.

nationwide
Official noticefda.gov
More recalls like this
5 related — by brand, contaminant, and category

Frequently asked questions

Is the TRAZODONE HYDROCHLORIDE recall still active?

Yes, this recall is currently active as of January 26, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Batch # 6160008A, Exp Date: 12/31/2026. Check the label on your product.

What should I do if I have the recalled TRAZODONE HYDROCHLORIDE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.