Teva recalls Buprenorphine/Naloxone tablets due to impurities
Teva Pharmaceuticals USA recalls specific lots of Buprenorphine and Naloxone sublingual tablets (2mg/0.5mg) due to failed impurities tests. These prescription-only products may contain unsafe levels of related compounds.
Recall notice
Failed Impurities/Degradation Specifications: out of specification test results for related compounds largest unknown impurity.
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling certain lots of Buprenorphine and Naloxone sublingual tablets (2 mg/0.5 mg, 30 tablets per bottle) because tests showed unsafe levels of impurities. This could pose a risk to users taking these prescription medications. Read more at govinfonow.com/recall/41518-teva-recalls-buprenorphine-naloxone-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/41518-teva-recalls-buprenorphine-naloxone-tablets-due-to-impurities · Updated October 8, 2026 · FDA enforcement record: FDA #D-0983-2017
Cite this page
“Teva recalls Buprenorphine/Naloxone tablets due to impurities.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41518-teva-recalls-buprenorphine-naloxone-tablets-due-to-impurities. Based on FDA recall #D-0983-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0983-2017%22&limit=1).
Why it’s dangerous
The tablets failed impurities tests, indicating the presence of unknown related compounds at levels that may not meet safety standards. This could potentially cause adverse effects in users who take the medication as prescribed.
Who’s affected
Prescription holders of the specific lots mentioned in the recall. People using these medications for opioid addiction treatment or pain management are most at risk.
How to tell if you have this one
Check the product label for the specific lot numbers: 30227613A, 30227614A, 30227615A (expiring 6/2017), 30228559A, 30228560A (expiring 9/2017), or 3000123 (expiring 7/2018).
- Brand
Teva- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in the USA
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0983-2017 | 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; Lot #: 30227613A, 30227614A, 30227615A, EXP 6/2017; 30228559A, 30228560A, EXP 9/2017; 3000123, EXP 7/2018 | 25264 bottles |
| D-0984-2017 | 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; Lot #: 30227649A ,30227650A, 30227651A, 30227652A, 30227653A, 30227654A, 30227655A, 30227832A, 30227833A, 30227834A, 30227835A, EXP 06/2017; 30228561A, 30228562A, 30228563A, 30228564A, 30228565A, 30228566A, 30228567A, 30228568A, 30228569A, 30228570A, EXP 9/2017; 3000124, 3000125, EXP 7/2018; 3000392, 3000393, 3000394, EXP 9/2018; 3000872, 3000874, EXP 10/2018; | 196275 bottles |
What to do — step by step
Check Product Label
Look for the lot numbers listed in the recall: 30227613A, 30227614A, 30227615A, 30228559A, 30228560A, or 3000123.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 10 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0983-2017 (June 29, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0983-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.