Cipla USA, Inc. is recalling one lot of Fosfomycin Tromethamine Granules for Oral Solution because the product failed impurity and degradation specifications. The affected item is a single-dose sachet equivalent to 3 grams of Fosfomycin, manufactured by Cipla Ltd. in India. The recall covers distribution nationwide in the USA. Read more at govinfonow.com/recall/1622878-cipla-usa-inc-recalls-fosfomycin-tromethamine-granules-for-oral-solution.
“Cipla Recalls Fosfomycin Tromethamine Granules Due to Impurities.” GovInfoNow, updated October 21, 2026. https://govinfonow.com/recall/1622878-cipla-usa-inc-recalls-fosfomycin-tromethamine-granules-for-oral-solution. Based on FDA recall #D-0014-2027 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0014-2027%22&limit=1).
The FDA announced on Sept. 18, 2026, that Cipla USA, Inc. voluntarily recalled Fosfomycin Tromethamine Granules due to failed impurity specifications. The recall affects lots manufactured by Cipla Ltd. in India.
How to tell if you have it
Brand: Cipla USA
Product: Fosfomycin Tromethamine Granules for Oral Solution (Equivalent to 3 Grams of Fosfomycin)
NDC: 69097-579-67
Lot Code: 5KA0405
Expiration Date: 12/31/2026
The hazard
The product failed impurity and degradation specifications, according to the FDA. The agency classified the recall as Class II.
Context
GovInfoNow's records show Cipla USA, Inc. has had 13 other recalls since June 27, 2023. Recent brand recalls include a Cinacalcet Tablets recall on June 29, 2026, for N-nitroso-cinacalcet over daily intake and another on March 16, 2026, for similar contamination risks. Other recent recalls of similar products include a Phytonadione Injectable Emulsion recall (Oct. 31, 2025), a Ciclopirox Shampoo 1% recall (Dec. 9, 2025), and a Fentanyl Citrate Injectable Solution recall (April 1, 2026).
How to tell if you have this one
Check your medication sachet for NDC 69097-579-67, Lot number 5KA0405, and an expiration date of 12/31/2026. The product is labeled as 'Rx only' and manufactured by Cipla Ltd.
Brand
Cipla USA
Category
Drug
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “USA Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 26 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
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-0014-2027 (September 18, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0014-2027 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 21, 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.