CLASS II Drug recall · Reported 24 Feb 2021 · FDA Enforcement Report
Cephalexin for Oral Suspension, USP 250 mg per (when mixed) recalled
Ascend Laboratories is recalling Cephalexin for Oral Suspension, USP 250 mg per (when mixed), distributed nationwide in the US. The recall was initiated on 22 Jan 2021 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-0263-2021
- FDA event ID
- 87214
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Jan 2021
- FDA classified
- 18 Feb 2021
- Reported
- 24 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Antibiotics
Timeline
| 22 Jan 2021 | Recall initiated by company | |
| 18 Feb 2021 | Classified by FDA | +27 days |
| 24 Feb 2021 | 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
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
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 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Which lots are affected?
Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022.
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 22 Oct 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 87214| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Cephalexin for Oral Suspension, USP 250 mg per (when mixed) recalled | Ascend Laboratories | Potency & Assay | Nationwide |
More recalls from Ascend Laboratories
All 51| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Amlodipine and Olmesartan Medoxomil Tablets, 10mg/40mg recalledAmlodipine And Olmesartan Medoxomil | Ascend Laboratories | Potency & Assay | Nationwide |
| 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 |
Other Cephalexin For recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalled | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cephalexin for Oral Suspension, USP, 125 mg per (when mixed) recalled | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cephalexin for Oral Suspension, USP 250 mg per (when mixed) recalled | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cephalexin for Oral Suspension, USP, 125 mg recalled | Ascend Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cephalexin for Oral Suspension, USP 250 mg per (when mixed) recalled | Ascend Laboratories | Potency & Assay | Nationwide |