FDA Drug recall D-0014-2027
Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by:…
- FDA Drug
- Class II
- ongoing
- Published 2026-10-14
On 2026-10-14 the FDA classified a Class II recall of Fosfomycin Tromethamine Granules for Oral Solution, (Equivalent to 3 Grams of Fosfomycin), 1 Single-Dose Sachet, Rx only, Manufactured by:… by Cipla Usa, citing failed Impurities/Degradation Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0014-2027 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-09-18 |
| Published | 2026-10-14 |
| Last updated | 2026-10-21 05:30 UTC |
| Company | Cipla Usa |
| Distribution | US |
Product
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
Failed Impurities/Degradation Specifications
Identifiers
| ndc | 69097-579-67 |
|---|---|
| code_info | Lot#: 5KA0405, Exp 12/31/2026. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-21 05:30 UTC. Current status: ongoing.
Other recalls by Cipla Usa
- Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-07-08 · Cipla Usa - Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-07-08 · Cipla Usa - Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-07-08 · Cipla Usa - Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-04-22 · Cipla Usa - Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India
FDA Drug · Class II · 2026-04-22 · Cipla Usa
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0014-2027%22
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