Teva Pharmaceuticals recalls Fentanyl Buccal Tablets (800mcg) due to missing or incorrect package inserts. This may affect safe use of prescription pain medication. Consumers should check product details and contact Teva for guidance.
Labeling: Incorrect or Missing Package Insert
Teva Pharmaceuticals is recalling Fentanyl Buccal Tablets (800mcg) because the package insert may be missing or incorrect. This could lead to improper use of a powerful opioid medication, especially since it's a prescription-only product.
The package insert is critical for safe use of this opioid medication. Without it, users may not understand proper dosing, storage, or potential side effects, which could lead to misuse or adverse reactions.
Prescription holders of Fentanyl Buccal Tablets (800mcg) with specific lot numbers and expiration dates. People using these tablets for pain management are most at risk if they don't have the correct package insert.
Check for lot numbers 42617832 (exp 06/2023), 42619530 (exp 08/2023), or 100020532 (exp 11/2024) on the carton. The product is a prescription-only opioid tablet package with 28 tablets (4 tablets x 7 cards).
Verify if the package insert is present and correct for your specific lot number.
The recall is due to missing or incorrect package inserts, which could affect safe use. However, the product itself is prescription-only and not inherently dangerous if used correctly.
Check for lot numbers 42617832 (exp 06/2023), 42619530 (exp 08/2023), or 100020532 (exp 11/2024) on the carton.
The recall does not specify a remedy, so contact Teva Pharmaceuticals for guidance on next steps.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0770-2023 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-0770-2023 from Teva Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
