AVEVA Buprenorphine Patch Recall: Impurities May Cause Harm
Recall of AVEVA Buprenorphine Transdermal Systems due to impurities detected at 18-month stability. Affected units may pose health risks; contact your doctor for guidance.
Lower-risk recall
Failed Impurities/Degradation Specifications: Out of specification for related substance 10-hydroxy buprenorphine N-Oxide results generated at the 18-month stability timepoint.
Contact the company
What happened, in plain English
AVEVA recalls buprenorphine patches that may contain impurities detected at the 18-month stability test. This could pose health risks, so affected users should consult their doctor. Read more at govinfonow.com/recall/33873-aveva-buprenorphine-patch-recall-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/33873-aveva-buprenorphine-patch-recall-impurities-may-cause-harm · Updated August 17, 2026 · FDA enforcement record: FDA #D-0466-2023
Cite this page
“AVEVA Buprenorphine Patch Recall: Impurities May Cause Harm.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33873-aveva-buprenorphine-patch-recall-impurities-may-cause-harm. Based on FDA recall #D-0466-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0466-2023%22&limit=1).
Why it’s dangerous
The patches may contain impurities that could cause health issues. The problem was detected during stability testing at 18 months, but the exact risk level isn't specified in the recall.
Who’s affected
People with prescriptions for buprenorphine patches from AVEVA. Those who have the specific lot number (51836) and expiration date (07/2023) are most at risk.
How to tell if you have this one
Check for the product name 'Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems'. Look for the lot number 51836 and expiration date 07/2023 on the packaging.
- Brand
AVEVA- 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
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0465-2023 | Buprenorphine Transdermal System, CIII 10 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7077-05; Lot#: 51835 Exp: 06/2023 | 11,520 cartons |
| D-0466-2023 | Buprenorphine Transdermal System, CIII 20 mcg/hour, 4 Transdermal Systems One package of 4 disposal units, Rx Only, Manufactured by: Aveva Drug Delivery Systems Inc. Miramar, FL. 33025, Manufactured for: Apotex Corp Weston, FL. 33326, NDC 60505-7079-05; Lot#: 51836 Exp: 07/2023 | 5,208 cartons |
What to do — step by step
Check Your Package
Look for the lot number 51836 and expiration date 07/2023 on the packaging.
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 14 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-0466-2023 (February 15, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0466-2023 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.