Teva Recalls Buprenorphine and Naloxone Tablets Due to Impurities
Teva Pharmaceuticals is recalling Buprenorphine and Naloxone Sublingual Tablets because test results showed out-of-specification impurities.
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard involves impurities without reported injuries, fitting the Moderate severity criteria for low-risk contamination or precautionary recalls.
Plain-English summary
Teva Pharmaceuticals USA is recalling Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg. The recall involves 196,275 bottles of the prescription medication, which were distributed nationwide in the USA.
The recall was initiated because the product failed impurities and degradation specifications. Specifically, test results indicated out-of-specification levels for related compounds and the largest unknown impurity.
Consumers should stop using the affected medication and contact their healthcare provider or pharmacist for guidance. The affected lot numbers and expiration dates are listed in the official recall notice.
The recalled product
- Product
- Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg 30 tablets per Bottle, Rx only, Distributed By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5721-56
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 196,275
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 (20)
- Lot #: 30227649A
- 30227650A
- 30227651A
- 30227652A
- 30227653A
- 30227654A
- 30227655A
- 30227832A
- 30227833A
- 30227834A
- 30227835A
- EXP 06/2017
- 30228561A
- 30228562A
- 30228563A
- 30228564A
- 30228565A
- 30228566A
- 30228567A
- 30228568A
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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