Lower riskDrug recall · FDA · Published July 18, 2023
Ascend Fosfomycin Granules Recall: Impurities Risk After 6 Months
Ascend Laboratories recalls Fosfomycin Tromethamine Granules for Oral Solution due to impurities detected after 6 months of storage. Affected lots from June 2024 to September 2024. No remedy specified.
“Ascend Fosfomycin Granules Recall: Impurities Risk After 6 Months.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33239-ascend-fosfomycin-granules-recall-impurities-risk-after-6-months. Based on FDA recall #D-1145-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1145-2023%22&limit=1).
The FDA announced on July 18, 2023, that Ascend Laboratories, LLC voluntarily recalled Fosfomycin Tromethamine Granules due to failed impurity specifications. The agency classified the recall as Class III.
How to tell if you have it
Brand: Ascend Laboratories
Product: Fosfomycin Tromethamine Granules for Oral Solution, 3 g single-dose sachet
NDC#: 67877-749-57
Lot codes: 22121970, 22122158, 22121971, 22122189, 22122190, 22122277, 22122278 (Exp June 2024); 22122521, 22122522, 22122523 (Exp July 2024); 22123328, 22123329, 22123330 (Exp September 2024)
The recall addresses out-of-specification results observed for the organic impurities test at six months of real-time stability. The FDA classified the product as Class III.
Context
GovInfoNow's records show Ascend Laboratories, LLC has 35 other recalls on record since November 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 Somerset Therapeutics Dexamethasone Injection Recall (February 4, 2026), Sagent Busulfan Injection Recall (May 4, 2026), and Sun Pharmaceutical Fluocinolone Acetonide Solution Recall (December 30, 2025).
How to tell if you have this one
Check the product label for the lot numbers listed: 22121970 through 22123330. The expiration dates range from June 2024 to September 2024.
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 listed in the recall notice: 22121970 through 22123330.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “The recall product was distributed nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4FDA terminated the recall
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-1145-2023 (July 18, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1145-2023 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.