CLASS II Drug recall · Reported 13 Jan 2021 · FDA Enforcement Report
Cephalexin for Oral Suspension, USP, 125 mg recalled
Ascend Laboratories is recalling Cephalexin for Oral Suspension, USP, 125 mg per, packaged as a) (when mixed), distributed nationwide in the US. The recall was initiated on 23 Nov 2020 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-0185-2021
- FDA event ID
- 86850
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Brand
- Cephalexin
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Nov 2020
- FDA classified
- 4 Jan 2021
- Reported
- 13 Jan 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 23 Nov 2020 | Recall initiated by company | |
| 4 Jan 2021 | Classified by FDA | +42 days |
| 13 Jan 2021 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
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, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Which lots are affected?
Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
Where was it sold?
Distributed 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.
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 17| 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 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 |