Venlafaxine Tablets 75 mg Recalled for Foreign Metal Material
Zydus Pharmaceuticals is recalling Venlafaxine 75 mg tablets due to a complaint of a metal shaving found embedded in a tablet. The recall affects 13,128 bottles distributed nationwide.
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 3/5 (High).
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 in a tablet could cause injury if ingested), and the source text does not report any actual illnesses or injuries to date, placing it at the high end of Class II / lower end of severity.
Plain-English summary
Zydus Pharmaceuticals (USA) Inc. is recalling Venlafaxine (Venlafaxine) Tablets, USP, 75 mg, in 100-count bottles. The recall was initiated due to a product complaint reporting the presence of foreign material resembling a metal shaving embedded in one tablet.
The affected product is Lot #M314265 with an expiration date of 31 October 2025. The recall involves 13,128 bottles distributed nationwide. The product is manufactured by Zydus Lifesciences Ltd, Ahmedabad, India, and distributed by Zydus Pharmaceuticals (USA) Inc., Pennington, NJ.
Patients who have received this medication should discontinue use if they suspect they have a contaminated tablet and consult their healthcare provider. Consumers with questions may contact the manufacturer or the FDA. Healthcare providers are advised to notify their patients about this recall.
The recalled product
- Product
- VENLAFAXINE (VENLAFAXINE)
- Brand
- VENLAFAXINE
- Manufacturer
- Zydus Pharmaceuticals (USA) Inc
- Category
- Drug — Prescription Tablet
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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