UnratedDrug recall · FDA · Published January 16, 2024
Ascend Laboratories Recalls Fosfomycin Granules Due to Impurities
Ascend Laboratories recalls specific batches of fosfomycin granules for oral solution due to failed impurities testing. This may affect prescription medication safety.
“Ascend Laboratories Recalls Fosfomycin Granules Due to Impurities.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32877-ascend-laboratories-recalls-fosfomycin-granules-due-to-impurities. Based on FDA recall #D-0339-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0339-2024%22&limit=1).
The FDA announced on Jan. 16, 2024, that Ascend Laboratories, LLC is recalling Fosfomycin Tromethamine Granules for Oral Solution due to failed impurity specifications. The recall affects 71,244 single-dose sachets distributed nationwide.
How to tell if you have it
Brand: Ascend Laboratories
Product: Fosfomycin Tromethamine Granules for Oral Solution (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only
The product failed organic impurity specifications, according to the FDA. The recall is classified as Class II.
Context
GovInfoNow's records show Ascend Laboratories, LLC has issued 35 other recalls since Nov. 2, 2016. Recent brand recalls include Dabigatran Etexilate Capsules recalled on July 16, 2026, due to impurity risks and Amlodipine/Olmesartan tablets recalled on July 8, 2026, for low drug content. Other recent recalls of similar products include Rising Pharma's Temozolomide 5mg Capsules recall (March 3, 2026) and Sun Pharmaceutical's Fluocinolone Acetonide Solution recall (Dec. 30, 2025).
How to tell if you have this one
Check the product label for the lot numbers listed: 22121458-22121969. The expiration dates range from March 2024 to May 2024. This is a prescription-only medication.
Brand
Ascend Laboratories
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Label
Look for the lot numbers 22121458 through 22121969 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 43 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #D-0339-2024 (January 16, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0339-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.