Zydus Recalls Venlafaxine Hydrochloride Tablets Due to Broken Tablets
Zydus Pharmaceuticals USA Inc. is recalling 13,320 bottles of Venlafaxine Hydrochloride 75 mg tablets due to a complaint of excessive broken or chipped tablets.
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 specific defect (broken/chipped tablets) is a physical quality issue rather than a chemical contamination or mislabeling of a high-risk allergen, fitting the 'Moderate' criteria for minor defects or low-risk issues without reported injuries.
Plain-English summary
Zydus Pharmaceuticals USA Inc. is recalling 13,320 bottles of Venlafaxine Hydrochloride Tablets, 75 mg, 100-count. The product is a prescription-only medication manufactured by Cadila Healthcare Ltd. in Ahmedabad, India, and distributed by Zydus Pharmaceuticals USA Inc. in Pennington, New Jersey. The specific lot number is MM8490 with an expiration date of 09/14.
The recall was initiated following a pharmacist complaint regarding an excessive amount of broken and/or chipped tablets found in the bottles. The affected product was distributed nationwide.
Consumers who have this specific lot of Venlafaxine Hydrochloride Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- VENLAFAXINE (VENLAFAXINE)
- Brand
- VENLAFAXINE
- Manufacturer
- Zydus Pharmaceuticals USA Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 13,320
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 #: MM8490
- Exp 09/14
UPCs (4)
- 0368382019011
- 0368382018014
- 0368382021014
- 0368382101013
Distribution
Distributed nationwide across the United States.
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