Bryant Ranch Recalls Venlafaxine Tablets Due to Labeling Error
Bryant Ranch Prepack Inc. is recalling venlafaxine hydrochloride extended-release tablets that were incorrectly labeled as immediate-release.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The hazard is a labeling error (mis-labeling) rather than a contamination or structural defect, fitting the Moderate severity criteria for minor labeling errors.
Plain-English summary
Bryant Ranch Prepack Inc. is recalling venlafaxine hydrochloride extended-release tablets (75 mg) that were incorrectly labeled as the immediate-release formulation. The product was manufactured by Teva Pharmaceuticals USA, Inc. and packaged by Bryant Ranch. The recall involves 21 bottles containing a total of 910 extended-release tablets.
The recall was initiated because Bryant Ranch received the extended-release tablets for repackaging but applied the wrong label, identifying them as immediate-release. This labeling error could lead to patients or healthcare providers dispensing or administering the wrong formulation of the medication.
Consumers and healthcare providers should check their inventory for venlafaxine hydrochloride tablets with Lot # 94983 and an expiration date of 10/17. If found, these products should be returned to the pharmacy or point of purchase for a refund or replacement. The affected NDCs include 63629-3324-2 and 63629-3324-6.
The recalled product
- Product
- VENLAFAXINE (VENLAFAXINE)
- Brand
- VENLAFAXINE
- Manufacturer
- Bryant Ranch Prepack Inc.
- Category
- Drug — Prescription Medication
- Hazard
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 # 94983
- Exp 10/17
Distribution
Distributed nationwide across the United States.
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