Agency classClass IIIOur severity:Low FDA (Drugs)·D-0983-2017·Announced 2017-07-26

Teva Recalls Buprenorphine and Naloxone Tablets Due to Impurities

Teva Pharmaceuticals is recalling specific lots of Buprenorphine and Naloxone Sublingual Tablets because they failed impurity specifications.

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 1/5 (Low).

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Teva Pharmaceuticals USA is recalling 25,264 bottles of Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg, 30 tablets per bottle. The affected product is distributed nationwide in the USA and is identified by NDC 0093-5720-56.

The recall was initiated because the product failed impurities and degradation specifications, specifically regarding out-of-specification test results for related compounds and the largest unknown impurity. The agency has classified this as a Class III recall.

The affected lots are 30227613A, 30227614A, and 30227615A (expiration 6/2017); 30228559A and 30228560A (expiration 9/2017); and 3000123 (expiration 7/2018). Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product matches the recalled lots, it should be returned to the pharmacy or distributor for disposal or replacement.

The recalled product

Product: Buprenorphine and Naloxone Sublingual Tablets, 2 mg/0.5 mg 30 tablets per bottle, Rx only, Distributed by: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5720-56
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Prescription Medication
Hazard: impurities
degradation
Affected units: 25,264

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 (9)

Lot #: 30227613A
30227614A
30227615A
EXP 6/2017
30228559A
30228560A
EXP 9/2017
3000123
EXP 7/2018

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