D-0014-2027 Class II Ongoing
FDA drug recall D-0014-2027 was initiated by Cipla USA, Inc. on Sep 18, 2026 and is designated Class II. Reason for recall: Failed Impurities/Degradation Specifications The recall status is ongoing.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 14, 2026
- Initiation Date
- Sep 18, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
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.
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution Pattern
USA Nationwide.
Code Information
Lot#: 5KA0405, Exp 12/31/2026.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0014-2027
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026