Granules Pharmaceuticals Inc. Recalls Trazodone Hydrochloride Due to Foreign Tablets
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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 April 6, 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 consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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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 ↗
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