Takeda Recalls Contrave Tablets Due to Broken or Split Defects
Takeda Pharmaceuticals is recalling 3,619 bottles of Contrave extended-release tablets due to potential tablet defects, including broken tablets and equatorial splitting.
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: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences. The defect is a physical specification failure (broken/split tablets) without reported injuries or illnesses, fitting the Moderate severity criteria for minor defects or low-risk issues.
Plain-English summary
Takeda Pharmaceuticals North America, Inc. is recalling 3,619 bottles of CONTRAVE (naltrexone HCl and bupropion HCl) extended-release tablets, 8 mg/90 mg, 120-count bottles. The recall involves Lot # B21642 with an expiration date of 03/17. The product is distributed nationwide.
The recall was initiated due to a failure in tablet specifications. Specifically, there is a potential defect involving broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components. This defect could affect the integrity of the medication.
Consumers and healthcare providers who have this specific lot of CONTRAVE should stop using it and contact their pharmacist or healthcare provider for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- CONTRAVE (naltrexone HCl and bupropion HCl )extended-release tablets, 8 mg/ 90 mg, 120-count bottle, Rx only, Manufactured for Orexigen Therapeutics, Inc., La Jolia, CA 92037, Distributed by Takeda Pharmaceuticals America, Inc., Deerfield, IL 60015, NDC 64764-890-99.
- Manufacturer
- Takeda Pharmaceuticals North America, Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 3,619
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 # B21642
- Exp. 03/17
Distribution
Distributed nationwide across the United States.
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