Teva Pharmaceuticals Fentanyl Buccal Tablets CII Recall

Why it was recalled

Labeling: Incorrect or Missing Package Insert

Product description

Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28

Lot numbers, UPCs & expiration codes

Lot# 42617828, Exp 06/2023; 100020465, Exp 01/2024

Where it was sold

US Nationwide

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0766-2023
Classification: Class III
Status: Terminated
Recall initiated: Apr 27, 2023
FDA report date: May 31, 2023
Quantity: 438
Recall type: Voluntary: Firm initiated
Recalling firm: Teva Pharmaceuticals USA Inc

Original FDA data

Every field from FDA enforcement report D-0766-2023, exactly as published.

Show all FDA fields

City: Parsippany
State: NJ
Status: Terminated
Country: United States
Event ID: 92133
Address: 400 Interpace Pkwy Bldg A
Code information: Lot# 42617828, Exp 06/2023; 100020465, Exp 01/2024
Postal code: 07054-1120
Report date: May 31, 2023
Product type: Drugs
Recall number: D-0766-2023
Classification: Class III
Recalling firm: Teva Pharmaceuticals USA Inc
Product quantity: 438
Termination date: Feb 29, 2024
Reason for recall: Labeling: Incorrect or Missing Package Insert
Voluntary / mandated: Voluntary: Firm initiated
Product description: Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28
Distribution pattern: US Nationwide
Recall initiation date: Apr 27, 2023
Initial firm notification: Letter
Center classification date: May 24, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0766-2023, published May 31, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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