Prescription Drug Trazodone Recalled Due to Foreign Tablet Contamination
Granules Pharmaceuticals Inc. is recalling Trazodone Hydrochloride 50 mg tablets due to the presence of foreign tablets or capsules in some bottles. Patients should stop use and contact their pharmacy.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving contamination of a prescription medication with foreign tablets or capsules, creating a risk of medication errors and unintended drug exposure. No illnesses or injuries have been reported in the source material, but the potential for serious harm warrants a High severity rating.
Plain-English summary
Granules Pharmaceuticals Inc. is recalling Trazodone Hydrochloride, USP, 50 mg tablets in 100-count bottles due to the presence of foreign tablets or capsules found in affected product bottles. The recalled product (NDC 70010-231-01) was manufactured by Granules India Limited and distributed nationwide in the United States.
The contamination poses a potential safety risk, as patients could inadvertently ingest an unknown medication. This is particularly concerning for a prescription antidepressant medication where taking the wrong medication could have serious health consequences.
The recall affects 71,424 bottles with batch number 6160008A and an expiration date of 12/31/2026. Patients who have this medication should stop using it and contact their pharmacy or healthcare provider for guidance on obtaining replacement medication.
The recalled product
- Product
- TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
- Brand
- TRAZODONE HYDROCHLORIDE
- Manufacturer
- Granules Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- contamination
- foreign-object
- medication-error-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # 6160008A
- Exp Date: 12/31/2026
UPCs (4)
- 0370010232013
- 0370010233010
- 0370010231016
- 0370010234017
Distribution
Distributed nationwide across the United States.
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