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# Teva Recalls Fentanyl Lots Over Product Insert
- URL: https://www.fdaweb.com/teva-recalls-fentanyl-lots-over-product-insert/
- Published: 2023-04-28T12:00:00.000Z
- Updated: 2026-09-14T18:28:22.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154327

Teva Pharmaceuticals has recalled 13 lots of various strengths of fentanyl buccal tablets due to safety updates that were omitted in the product insert/medication guide materials that are provided with the affected lots. Teva manufactured and labeled the products exclusively for Mayne Pharma, a [recall notice ](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-initiates-voluntary-nationwide-recall-specific-lots-fentanyl-buccal-tablets-cii-due-labeling?utm%5Fmedium=email&utm%5Fsource=govdelivery)says.

The notice says that the main safety concern is the potential for incomplete information needed by health care providers and patients regarding the product’s safe use. “Not following, or not being aware of, the omitted safety updates in the product insert/medication guide could lead to life-threatening adverse events; although, based on a Health Hazard Assessment conducted by Teva, the likelihood of the harm occurrence is considered remote,” it says. To date, Teva has not received any complaints.

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