Trazodone tablets recalled after complaints of a dent on the tablet surface
Zydus Pharmaceuticals is recalling 2,136 bottles of traZODONE Hydrochloride Tablets, 100mg, after a product complaint that some tablets had a dent on the plain side of the tablet surface.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: Scored 1 under the cosmetic defect criterion: the record cites a dent on the tablet surface with no stated clinical consequence.
Plain-English summary
traZODONE Hydrochloride Tablets, USP, 100mg, in 1,000-tablet bottles, manufactured by Zydus Lifesciences Ltd. of India and distributed by Zydus Pharmaceuticals (USA) Inc. of Pennington, New Jersey, under NDC 68382-806-10, are being recalled.
The reason given in the enforcement record is failed tablet or capsule specifications: a product complaint was received that some tablets had a dent on the plain side of the tablet surface.
The recall covers 2,136 1000-count bottles from lot EA00237A, expiry 04/30/2027. Distribution was nationwide in the USA. The FDA has classified the action as Class III, its least serious category.
The record describes a surface appearance defect and states no clinical consequence or reported harm. Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist.
The recalled product
- Product
- TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
- Brand
- TRAZODONE HYDROCHLORIDE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Antidepressant
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)
- Lot # EA00237A
- Exp Date: 04/30/2027
UPCs (1)
- 0368382808011
Distribution
Distributed nationwide across the United States.
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