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Food & drug recall · FDAMay 23, 2025Serious

Ascend Laboratories, LLC — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only

Do not stop taking this without speaking to your pharmacist or doctor.

What’s wrong

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.

The Recall Registry rates this serious — FDA Class II: temporary or medically reversible health harm.

What to do

Check the lot numbers below against what you have. Do not stop taking a prescription medicine because of a recall without speaking to your pharmacist or doctor first — for many medicines stopping is more harmful than continuing, and they can tell you whether yours is affected and what to do about it.

Who to contact: Recalling firm: Ascend Laboratories, LLC

The product

Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88

Details

Units affected
48,936 - 100 mL bottles
Recall date
May 23, 2025
Brand
Ascend Laboratories, LLC
Model, lot or SKU numbers
Lot #: 23141828, 23141829, Exp Date: 5/31/202523142342, Exp Date: 6/30/202523142708, Exp Date: 7/31/202523144035, Exp Date: 10/31/202523144270, Exp Date: 11/30202524140026, Exp Date: 12/31/2025
Where it was distributed

Nationwide in the USA

The official notice

This recall was issued by the U.S. Food and Drug Administration. The Recall Registry summarises it — always confirm the details at the source.

Their exact wording: “Ascend Laboratories, LLC — Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories Ltd., India, Distributed by: Ascent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-88”

Read it on FDA →

Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.

Filed under: Prescription medicine

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