Teva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
Teva Pharmaceuticals is recalling 175,392 bottles of Trazodone Hydrochloride 50 mg tablets because they may contain foreign tablets or capsules.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While specific injury reports are not detailed in the text, the presence of foreign objects in a prescription drug is a significant safety hazard that aligns with the Severe classification for Class II drug recalls.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 175,392 bottles of Trazodone Hydrochloride Tablets, USP, 50 mg. The recall was initiated because the product may contain foreign tablets or capsules.
The affected product is identified by Lot 1394026 with an expiration date of 02/2028. The tablets were manufactured in Croatia by Pliva Hrvatska d.o.o. and distributed nationwide in the United States.
Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- TRAZODONE HYDROCHLORIDE (TRAZODONE HYDROCHLORIDE)
- Brand
- TRAZODONE HYDROCHLORIDE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 175,392
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: 1394026
- Exp. 02/2028.
UPCs (1)
- 0350111450011
Distribution
Distributed nationwide across the United States.
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