Granules Pharmaceuticals Inc. Recalls Trazodone Hydrochloride Due to Foreign Tablets

Source: FDA · United States

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Granules Pharmaceuticals Inc. has voluntarily recalled 71,424 bottles of Trazodone Hydrochloride (50 mg) after foreign tablets or capsules were discovered in the product.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 17, 2026 and geographically references United States. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Granules Pharmaceuticals Inc. has initiated a voluntary Class II recall of Trazodone Hydrochloride tablets. The recall was issued following reports of the presence of foreign tablets or capsules within the medication bottles, which were manufactured by Granules India Limited.

Which Products Are Affected

The recall involves Trazodone Hydrochloride, USP, 50 mg, distributed in 100-count bottles. The following specific details identify the affected products:

  • Product Name: Trazodone Hydrochloride, USP, 50 mg
  • Manufacturer: Granules Pharmaceuticals Inc.
  • NDC Number: 70010-231-01
  • Batch Number: 6160008A
  • Expiration Date: 12/31/2026
  • UPCs: 0370010231030, 0370010232037, 0370010234031, 0370010233034
  • Quantity: 71,424 bottles
  • Distribution: Nationwide across the United States

What You Should Do

Consumers who have the affected batch of Trazodone Hydrochloride should immediately stop using the medication. You should contact your healthcare provider to discuss alternative treatments and reach out to Granules Pharmaceuticals Inc. in Chantilly, VA, for further instructions regarding the return or disposal of the product.

Why This Matters

The presence of foreign tablets or capsules in a prescription medication bottle poses a significant health risk, as patients may accidentally ingest the wrong drug, leading to potentially serious adverse reactions or medical complications.

Source

Attribution: FDA (Recall Number: D-0305-2026)

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Granules Pharmaceuticals Inc. has voluntarily recalled 71,424 bottles of Trazodone Hydrochloride (50 mg) after foreign tablets or capsules were discovered in the product.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "high" severity. Take precautions and monitor for updates.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.