Teva recalls Buprenorphine Naloxone tablets due to impurities
Teva Pharmaceuticals USA recalls 8mg/2mg sublingual buprenorphine and naloxone tablets with failed impurities specifications. Rx-only product distributed in HDPE bottles.
Recall notice
Failed Impurities/Degradation Specifications
Contact the company
What happened, in plain English
Teva Pharmaceuticals is recalling 8 mg/2 mg bupren: 30-count HDPE bottles that failed impurities tests. This could pose a risk of harmful substances entering the bloodstream through sublingual use. Read more at govinfonow.com/recall/42048-teva-recalls-buprenorphine-naloxone-tablets-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/42048-teva-recalls-buprenorphine-naloxone-tablets-due-to-impurities · Updated October 8, 2026 · FDA enforcement record: FDA #D-0517-2017
Cite this page
“Teva recalls Buprenorphine Naloxone tablets due to impurities.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42048-teva-recalls-buprenorphine-naloxone-tablets-due-to-impurities. Based on FDA recall #D-0517-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0517-2017%22&limit=1).
Why it’s dangerous
The tablets failed impurities and degradation specifications, meaning they may contain harmful substances that could enter the bloodstream when used sublingually. This could lead to adverse effects from the impurities.
Who’s affected
People with prescriptions for these specific buprenorphine and naloxone tablets. Those who have the 30-count HDPE bottles with NDC 0093-5721-56 and lot 30227056A are most at risk.
How to tell if you have this one
Check for 30-count HDPE bottles labeled 'Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg'. Look for NDC 0093-5721-56 and lot number 30227056A on the bottle.
- Brand
Teva- Category
Drug
What to do — step by step
Check Product Details
Identify the NDC code 0093-5721-56 and lot number 30227056A on the bottle to confirm if it's recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 12 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0517-2017 (February 7, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0517-2017 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.