Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0984-2017·Announced 2017-07-26

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.

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 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: impurities
degradation
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.

See all 2 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · impurities