Trazodone tablets recalled over the presence of foreign tablets
Granules Pharmaceuticals is recalling 71,424 bottles of Trazodone Hydrochloride, USP 50 mg, over the presence of foreign tablets or capsules.
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: Scored 3 under the risk-of-harm criterion: foreign tablets in a prescription bottle can lead to a patient taking the wrong medicine, and no injuries are reported.
Plain-English summary
Trazodone Hydrochloride, USP, 50 mg, in 100-count bottles, Rx only, manufactured by Granules India Limited of Hyderabad, India for Granules Pharmaceuticals Inc. of Chantilly, Virginia, under NDC 70010-231-01, is being recalled.
The reason given in the enforcement record is the presence of foreign tablets or capsules.
The record lists 71,424 bottles from batch 6160008A, expiry 12/31/2026. Distribution was nationwide in the US. The FDA has classified the action as Class II.
A bottle containing tablets other than the one prescribed can lead to a patient taking the wrong medicine. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.
The recalled product
- Product
- TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
- Brand
- TRAZODONE HYDROCHLORIDE
- Manufacturer
- Granules Pharmaceuticals Inc.
- Category
- Drug — Antidepressant
- Affected units
- 71,424
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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