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Trazodone Hydrochloride 50 mg Tablets
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DRUG RECALLMODERATE

Trazodone Hydrochloride 50 mg Tablets

Granules Pharmaceuticals is recalling Trazodone Hydrochloride 50 mg tablets (NDC 70010-231-01) due to foreign tablets or capsules in bottles.

What to do

Do not use this medication if you have a bottle with NDC 70010-231-01. Contact your pharmacy or healthcare provider immediately to obtain a replacement or alternative medication. Return the affected bottle to your pharmacy.

Recalled
Listed
Updated
Recall No.
D-0305-2026
Agency
FDA
Firm
Granules Pharmaceuticals Inc.
Recall ID
98345
Status
ONGOING

Recall at a glance

Quantity recalled
71424 bottles.

Why it was recalled

Granules Pharmaceuticals Inc. is recalling Trazodone Hydrochloride, USP, 50 mg tablets (NDC 70010-231-01, 100-count bottles) due to the presence of foreign tablets or capsules in some bottles. The affected product was manufactured by Granules India Limited and distributed nationwide. Patients should contact their pharmacy or healthcare provider immediately if they have this medication.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Trazodone Hydrochloride, USP

Strength
50 mg
NDC / UPC
NDC 70010-231-01

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated
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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification