Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only
Summary
The FDA issued a Class II for Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fo by Cipla USA, Inc.. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0014-2027
Action Date
2026-10-14
Status
Ongoing
Category
drug
Product Description
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by: Cipla Ltd., Kurkumbh-413802, Maharashtra, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-579-67.
Lot/Code Info: Lot#: 5KA0405, Exp 12/31/2026.
Quantity Affected: N/A
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
USA Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-09-18
Company
Warren, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 43 drug recalls issued in the same week, part of 67 drug-related FDA actions this month.
Cipla USA, Inc. has 24 FDA actions in our database, including 24 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Cipla USA, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Cipla USA, Inc. have FDA actions?
Cipla USA, Inc. has 24 FDA actions in our database, including 24 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0014-2027" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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