Ascend Laboratories, LLC 2025-06-18 Health serious FDA
Health · FDA · Recall #FDA-D-0469-2025
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only,… Recall
Issued June 18, 2025 · Ascend Laboratories, LLC
In June 2025, Ascend Laboratories, LLC recalled the Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only,…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Failed Impurities/Degradation Specifications An out-of-specification result was observed in the related substance test at the sixth month of stability analysis. The individual impurity was identified to be Cephalexin Glucose Adduct.
What you should do
- 1 Stop using Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), 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
- June 18, 2025
- Units affected
- Not reported
- Sold at
- Nationwide in the USA.
- Recall number
- FDA-D-0469-2025
- Made in
- United States
- Issuing agency
- FDA
In context
- Ascend Laboratories, LLC has 12 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 691st Health recall we've logged in 2025.