Fentanyl buccal recalls

The FDA has published 5 recalls involving Fentanyl buccal since 2023. The latest was reported on 31 May 2023. Most were for packaging defects. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls5since 2023

Last 12 months0reported

Class I00% of total

Ongoing0latest 31 May 2023

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 0 0%Class III 5 100%

Why fentanyl buccal is recalled

Packaging Defects5100%

Companies

Teva Pharmaceuticals USA5100%

By year

20235100%

All fentanyl buccal recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
31 May 2023Drug	CLASS III	Fentanyl Buccal Tablets CII, 100mcg recalled by Teva Pharmaceuticals USA	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
31 May 2023Drug	CLASS III	Fentanyl Buccal Tablets CII, 800mcg recalled by Teva Pharmaceuticals USA	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
31 May 2023Drug	CLASS III	Fentanyl Buccal Tablets CII, 200mcg recalled by Teva Pharmaceuticals USA	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
31 May 2023Drug	CLASS III	Fentanyl Buccal Tablets CII, 400mcg recalled by Teva Pharmaceuticals USA	Teva Pharmaceuticals USA	Packaging Defects	Nationwide
31 May 2023Drug	CLASS III	Fentanyl Buccal Tablets CII, 600mcg recalled by Teva Pharmaceuticals USA	Teva Pharmaceuticals USA	Packaging Defects	Nationwide

Should you stop taking Fentanyl buccal?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.