Venlafaxine 50 mg Tablets Recalled for Wrong Strength
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets labeled as 50 mg because bottles contain Venlafaxine 37.5 mg tablets, creating a dosing error risk.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving labeling error that could result in incorrect dosing of a prescription antidepressant. The source text does not report any actual illnesses or injuries, making this a moderate labeling/content discrepancy rather than a severe adverse-event recall.
Plain-English summary
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Venlafaxine Tablets, USP 50 mg (100-tablet bottles, NDC 16714-657-01, batch code AVK1175A, expiration 9/2023) manufactured by ALKALOIDA Chemical Company and distributed through Northstar Distribution Center in Memphis, Tennessee.
The recalled product is mislabeled. Bottles marked as containing Venlafaxine 50 mg actually contain Venlafaxine 37.5 mg tablets. This strength discrepancy poses a medication error risk, as patients may receive an incorrect dose of their antidepressant medication.
Consumers who have purchased this product should not take it and should contact their pharmacy or healthcare provider immediately. The product should not be used until the correct medication is obtained.
The recalled product
- Product
- Venlafaxine Tablets, USP 50 mg*, 100 Tablets Manufactured for Northstar Rx LLC Memphis, TN 38141 Manufactured by: ALKALOIDA Chemical Company Zrt. 4440 Tiszavasvari, Kabay Janos u.29.Hungary. Product of India NDC 16714-657-01
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Affected units
- 2,856
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)
- AVK1175A
- exp 9/2023
Distribution
Distributed in 1 state:
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