Teva Fentanyl Buccal Tablets Recall: Missing Package Insert Risk
Teva Pharmaceuticals recalls Fentanyl Buccal Tablets (600mcg) due to missing or incorrect package inserts. This could lead to improper use. Affected units include specific lots from Mayne Pharma.
Recall notice
Labeling: Incorrect or Missing Package Insert
Contact the company
What happened, in plain English
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (600mcg) because the package insert may be missing or incorrect. This could lead to improper use of the medication, which is dangerous for patients. Read more at govinfonow.com/recall/33630-teva-fentanyl-buccal-tablets-recall-missing-package-insert-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/33630-teva-fentanyl-buccal-tablets-recall-missing-package-insert-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0769-2023
Cite this page
“Teva Fentanyl Buccal Tablets Recall: Missing Package Insert Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33630-teva-fentanyl-buccal-tablets-recall-missing-package-insert-risk. Based on FDA recall #D-0769-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0769-2023%22&limit=1).
Why it’s dangerous
The missing or incorrect package insert means patients may not receive clear instructions on how to use the medication safely. This could lead to improper administration, which is especially risky for a potent opioid.
Who’s affected
Patients prescribed Fentanyl Buccal Tablets by a doctor are affected. Those using the medication without proper instructions are at higher risk.
How to tell if you have this one
Check for the specific lot numbers: 42617831 (expiring June 2023), 42619585 (expiring November 2023), and 100029649 (expiring November 2024). The product is sold in cartons of 28 tablets (4 tablets per card, 7 cards).
- Brand
Teva Pharmaceuticals- Category
Drug
All 5 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
US Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0766-2023 | 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# 42617828, Exp 06/2023; 100020465, Exp 01/2024 | 438 |
| D-0767-2023 | Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28; Lot #: 100020528, Exp 09/2024; 100026699, Exp 11/2024 | 397 |
| D-0768-2023 | Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28; Lot#: 100020351, Exp 11/2024; 100020522, Exp 09/2024; 100026700, Exp 11/2024 | 1272 |
| D-0769-2023 | Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28; Lot#: 42617831, Exp 06/2023; 42619585, Exp 11/2023; 100029649, Exp 11/2024 | 1908 |
| D-0770-2023 | Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28; Lot#: 42617832, Exp 06/2023; 42619530, Exp 08/2023; 100020532, Exp 11/2024 | 3032 |
What to do — step by step
Check Package Insert
Ensure the package insert is present and correct before using the medication.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US 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 10 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.
Similar recalls
Other Teva Pharmaceuticals recalls
Keep exploring
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-0769-2023 (April 27, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0769-2023 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.