Reported Jun 18, 2025 · Ongoing
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only, Manufactured by: Alkem Laboratories…
Ascend Laboratories, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ascend Laboratories, LLC · 339 Jefferson Rd Ste 101 · Parsippany, NJ · 07054-3707
Is this the product you have?
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx Only
- Manufactured byAlkem Laboratories Ltd., India
- Distributed byAscent Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-544-68
- Lot codes and dates
- Lot #: 23142343
- Exp Date
6/30/202523143526
- Exp Date
9/30/202523144036
- Exp Date
10/31/202523144269
- Exp Date
11/30/2025Lot 24140027
- Exp Date
12/31/202524144282
- Exp Date10/31/2026
- Amount recalled
- 10,620 - 200 mL bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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