Ascend Laboratories, LLC 2025-07-23 Health serious FDA
Health · FDA · Recall #FDA-D-0534-2025
Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only,… Recall
Issued July 23, 2025 · Ascend Laboratories, LLC
In July 2025, Ascend Laboratories, LLC recalled the Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only,…, a serious health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Dana Whitfield, RecallCheckr
What this means for you
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
What you should do
- 1 Stop using Rizatriptan Benzoate Tablets, USP, 10 mg, 18 (3x6) Unit Dose Tablets, Rx Only,… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Ascend Laboratories, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Ascend Laboratories, LLC
- Category
- Health
- Recall date
- July 23, 2025
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-D-0534-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Ascend Laboratories, LLC has 15 recalls in our database.
- We're tracking 3,707 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.