CLASS III Drug recall · Reported 13 Sep 2023 · FDA Enforcement Report
Fosfomycin Tromethamine Granules recalled by Ascend Laboratories
Ascend Laboratories is recalling Fosfomycin Tromethamine Granules for Oral Solution single- dose sachet, distributed nationwide in the US. The recall was initiated on 18 Jul 2023 and the FDA has classified it as Class III.
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-1145-2023
- FDA event ID
- 92706
- Recalling firm
- Ascend Laboratories, Parsippany, NJ
- Manufacturer
- Ascend Laboratories, LLC
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jul 2023
- FDA classified
- 6 Sep 2023
- Reported
- 13 Sep 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 18 Jul 2023 | Recall initiated by company | |
| 6 Sep 2023 | Classified by FDA | +50 days |
| 13 Sep 2023 | Published in enforcement report | +7 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: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
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, 3 g 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
The recall product was distributed nationwide.
Questions about this recall
Is Fosfomycin Tromethamine Granules for Oral Solution single- dose sachet recalled?
Yes. Ascend Laboratories recalled Fosfomycin Tromethamine Granules for Oral Solution single- dose sachet on 18 Jul 2023. The recall is Class III and its status is Terminated. Recall number D-1145-2023.
Why was it recalled?
Failed Impurities/Degradation Specifications: Out-of-specification results observed for the organic impurities test at 6 months, RT Stability.
Which lots are affected?
Lot #22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278, Exp June 2024; 22122521, 22122522, 22122523, Exp July 2024; 22123328, 22123329, 22123330, Exp September 2024.
Where was it sold?
The recall product was distributed 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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
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 II | Fosfomycin Tromethamine Granules for Oral Solution recalledFosfomycin Tromethamine | Ascend Laboratories | Potency & Assay | Nationwide |