CLASS II ONGOING Drug recall · Reported 28 Feb 2024 · FDA Enforcement Report
Fosfomycin Tromethamine Granules for Oral Solution recalled
Ascend Laboratories is recalling Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to of fosfomycin), distributed nationwide in the US. The recall was initiated on 16 Jan 2024 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-0339-2024
- FDA event ID
- 93816
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Jan 2024
- FDA classified
- 20 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 16 Jan 2024 | Recall initiated by company | |
| 20 Feb 2024 | Classified by FDA | +35 days |
| 28 Feb 2024 | 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 Specification: Out of specification for organic impurities
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
Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57
Where it was distributed
Nationwide in the USA
Questions about this recall
Is Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to of fosfomycin) recalled?
Yes. Ascend Laboratories recalled Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to of fosfomycin) on 16 Jan 2024. The recall is Class II and its status is Ongoing. Recall number D-0339-2024.
Why was it recalled?
Failed Impurities/Degradation Specification: Out of specification for organic impurities
Which lots are affected?
lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024; 22121176, 22121407, 22121465, Exp 3/2024; 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.
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 21 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 Fosfomycin Tromethamine recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Fosfomycin Tromethamine Granules recalled by Ascend LaboratoriesFosfomycin Tromethamine | Ascend Laboratories | Potency & Assay | Nationwide |