Aurobindo Recalls Venlafaxine Hydrochloride Capsules Due to Physical Defects
Aurobindo Pharma USA Inc is recalling 47,040 bottles of Venlafaxine Hydrochloride extended-release capsules because some contain punctured or clumped capsules.
What this means for you
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: The recall is classified as FDA Class II, but the source text describes physical defects (punctured/clumped capsules) without reporting any illnesses, injuries, or specific high-risk contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Aurobindo Pharma USA Inc is voluntarily recalling 47,040 bottles of Venlafaxine Hydrochloride extended-release capsules, 37.5 mg, 30-count bottles. The recall is due to a failure in tablet and capsule specifications, specifically that some bottles contain punctured, and/or clumped or melted capsules.
The affected product is identified by Lot Number VI3716010-A and has an expiration date of 04/2018. The product was distributed nationwide in the United States. The capsules are manufactured by Aurobindo Pharma Limited in Hyderabad, India, for Aurobindo Pharma USA, Inc. in Dayton, New Jersey.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II, indicating a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VENLAFAXINE HYDROCHLORIDE (VENLAFAXINE HYDROCHLORIDE)
- Brand
- VENLAFAXINE HYDROCHLORIDE
- Manufacturer
- Aurobindo Pharma USA Inc
- Category
- Drug — Prescription Medication
- Affected units
- 47,040
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 #: VI3716010-A
- Exp. 04/2018
UPCs (2)
- 0365862528476
- 0365862527479
Distribution
Distributed nationwide across the United States.
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