CLASS II ONGOING Drug recall · Reported 18 Jun 2025 · FDA Enforcement Report
Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalled
Ascend Laboratories is recalling Cephalexin for Oral Suspension, USP, 125 mg per (when mixed), distributed nationwide in the US. The recall was initiated on 23 May 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0468-2025
- FDA event ID
- 96912
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Brand
- Cephalexin
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 23 May 2025
- FDA classified
- 12 Jun 2025
- Reported
- 18 Jun 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 23 May 2025 | Recall initiated by company | |
| 12 Jun 2025 | Classified by FDA | +20 days |
| 18 Jun 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it 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.
Which lots are affected?
Lot #: 23141828, 23141829, Exp Date: 5/31/2025; 23142342, Exp Date: 6/30/2025; 23142708, Exp Date: 7/31/2025; 23144035, Exp Date: 10/31/2025; 23144270, Exp Date: 11/302025; 24140026, Exp Date: 12/31/2025
Where was it sold?
Nationwide in the USA.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 96912This product is part of a recall event; the main page for the event is Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalledCephalexin | Ascend Laboratories | Potency & Assay | Nationwide |
More recalls from Ascend Laboratories
All 50| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Dabigatran Etexilate Capsules, 150 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran Etexilate Capsules, 75 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Dabigatran etexilate Capsules, 110 mg recalled by Ascend LaboratoriesDabigatran Etexilate | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
Other Cephalexin recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalledCephalexin | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |