Ascend Laboratories recalls Cephalexin oral suspension with potential impurity issues. Affected lots manufactured by Alkem Laboratories in India. Consumers should check NDC and expiration dates for affected products.
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.
Ascend Laboratories has recalled Cephalexin oral suspension products due to an impurity detected in stability testing. This impurity, Cephalexin Glucose Adduct, could pose a risk if the medication is used beyond the stability period.
The medication showed an impurity (Cephalexin Glucose Adduct) during stability testing at six months. This impurity could potentially cause adverse effects if the product is used beyond its stability period.
Prescription holders of Cephalexin oral suspension with specific lot numbers and expiration dates listed in the recall. Patients using this medication for infections are most at risk if the product is used after the stability period.
Check the NDC number 67877-544-88 and lot numbers 23141828, 23141829, 23142342, 23142708, 23144035, 23144270, 24140026. Products with expiration dates from May 31, 2025 through December 31, 2025 are affected.
Verify the NDC number and lot numbers listed in the recall to confirm if your product is affected.
The recall indicates a potential impurity detected during stability testing, but the product is still safe for use within the expiration date if no other issues are present.
Check the NDC number and lot numbers listed in the recall. If affected, contact your healthcare provider for guidance on safe alternatives.
Look for the NDC number 67877-544-88 and lot numbers 23141828 through 24140026 with expiration dates from May 31, 2025 through December 31, 2025.
We’ve drafted a message you can send Ascend Laboratories to request your refund or repair — edit it as you like.
Subject: Recall D-0468-2025 — Ascend Laboratories Ascend Laboratories Hello, I own a Ascend Laboratories that is covered by recall D-0468-2025 from Ascend Laboratories. 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.
