Prescription Drug Recall: Venlafaxine Tablets Contaminated With Foreign Metal Material
Zydus Pharmaceuticals is recalling Venlafaxine 75 mg tablets due to a metal shaving discovered embedded in one tablet. Consumers who have this product should stop using it and contact their pharmacy or healthcare provider.
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: This is an FDA Class II recall involving a risk-of-harm product (foreign material contamination in a prescription medication). Per the severity rubric, risk-of-harm products where no injuries or illnesses have been reported score as High (3).
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine Tablets, USP 75 mg, due to the presence of foreign material embedded in one tablet. Specifically, a metal shaving was discovered in a tablet from the affected lot. Foreign material in a medication tablet poses a potential risk of harm if the tablet is ingested.
The recall involves 13,128 bottles containing 100 tablets each. The affected lot is #M314265 with an expiration date of October 31, 2025. The product was distributed nationwide in the United States.
Consumers who have this product should stop using it and contact their pharmacy or healthcare provider. The product is identified as VENLAFAXINE Tablets, USP 75 mg, 100 Tablets, Rx only, manufactured by Zydus Lifesciences Ltd. (Ahmedabad, India) and distributed by Zydus Pharmaceuticals (USA) Inc. (Pennington, NJ).
The recalled product
- Product
- VENLAFAXINE (VENLAFAXINE)
- Brand
- VENLAFAXINE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug
- Hazard
- foreign-material
- contamination
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 #: M314265
- Exp.: 31 October 2025.
UPCs (4)
- 0368382019011
- 0368382018014
- 0368382021014
- 0368382101013
Distribution
Distributed nationwide across the United States.
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