CLASS II Drug recall · Reported 17 Nov 2021 · FDA Enforcement Report
Cefixime Capsules 400 mg recalled by Ascend Laboratories
Ascend Laboratories is recalling Cefixime Capsules 400 mg, distributed nationwide in the US. The recall was initiated on 3 Nov 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-0229-2022
- FDA event ID
- 88982
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Brand
- Cefixime
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Nov 2021
- FDA classified
- 9 Nov 2021
- Reported
- 17 Nov 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 3 Nov 2021 | Recall initiated by company | |
| 9 Nov 2021 | Classified by FDA | +6 days |
| 17 Nov 2021 | Published in enforcement report | +8 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
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
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot 20140282, exp Dec 2021
Where was it sold?
Nationwide
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 Cefixime recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefixime for Oral Suspension USP, 100 mg recalledCefixime | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefixime for Oral Suspension USP 200 mg/ Pack size) recalledCefixime | Lupin Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Cefixime for Oral Suspension 100mg recalled by Lupin PharmaceuticalsCefixime | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefixime 400 mg capsule, packaged in a) 2-count bottle recalled | RemedyRepack | Potency & Assay | MI, PA |
| Drug | CLASS II | Cefixime Capsules, 400 mg recalled by Ascend LaboratoriesCefixime | Ascend Laboratories | Potency & Assay | Nationwide |