Teva Pharmaceuticals USA recalls Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured
Teva Pharmaceuticals recalls Buprenorphine Transdermal Systems due to failed stability tests. The patches may not release medication properly, risking ineffective treatment. Check your carton number for affected lots.
Lower-risk recall
Failed Stability Specifications: Below specification result for buprenorphine release rate.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals is recalling Buprenorphine Transdermal Systems that failed stability tests. This means the medication might not release the correct dose, leading to ineffective treatment. Affected products were manufactured in specific lots with expiration dates. Read more at govinfonow.com/recall/36785-teva-buprenorphine-patch-recall-failed-stability-specifications.
Source Summary by GovInfoNow · govinfonow.com/recall/36785-teva-buprenorphine-patch-recall-failed-stability-specifications · Updated October 4, 2026 · FDA enforcement record: FDA #D-0003-2021
Cite this page
“Teva Buprenorphine Patch Recall: Failed Stability Specifications.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36785-teva-buprenorphine-patch-recall-failed-stability-specifications. Based on FDA recall #D-0003-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0003-2021%22&limit=1).
Why it’s dangerous
The patches failed stability tests, meaning they may not release buprenorphine at the correct rate. This could result in the medication not working properly, leading to ineffective treatment. However, the recall does not indicate immediate danger to health.
Who’s affected
Prescription patients using the Buprenorphine Transdermal System 5 mcg/hour. Those with the specific lot numbers and expiration dates listed in the recall are most at risk.
How to tell if you have this one
Check your carton for NDC 0093-3656-40 and patch NDC 0093-3656-21. The affected lots are 190017 (expiring 02/2021) and 190161 (expiring 08/2021).
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Product Details
Look for carton NDC 0093-3656-40 and patch NDC 0093-3656-21 on the packaging.
Contact Your Doctor
Talk to your healthcare provider about alternative treatment options if you have the recalled product.
Questions people ask
What is the specific problem with these patches?
The patches failed stability tests, meaning they may not release buprenorphine at the correct rate, which could lead to ineffective treatment.
Which lots are affected?
Lots 190017 (expiring 02/2021) and 190161 (expiring 08/2021).
Do I need to stop using the patches immediately?
No, the recall indicates a low risk of ineffective treatment, not immediate danger. Contact your doctor for advice.
Contact Teva Pharmaceuticals
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0003-2021 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0003-2021 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Similar recalls
Keep exploring
From people who’ve dealt with this
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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-0003-2021 (September 4, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0003-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.