FDAClass II · Drug · Recall D-0014-2027 · Recalled October 14, 2026

Fosfomycin Tromethamine Granules for Oral Solution recall — Cipla USA, Inc.

Agency report date: October 14, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named: Fosfomycin Tromethamine Granules for Oral Solution
Company / brand: Cipla USA
Lot / serial / date codes: Lot#: 5KA0405, Exp 12/31/2026.
Distribution: USA Nationwide.

Agency product description and boundaries

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.

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Failed Impurities/Degradation Specifications

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Fosfomycin Tromethamine Granules for Oral Solution recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0014-2027
Brand: All Cipla USA recalls
Classification: Class II
Units affected: N/A
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

Fosfomycin Tromethamine Granules for Oral Solution recall status

Companies & origin

Recalling firm location: Warren, NJ, United States
Firm address: 10 Independence Blvd, N/A, 07059-2730

Identifying details (verbatim from the notice)

Product codes / lots: Lot#: 5KA0405, Exp 12/31/2026.
Distribution: USA Nationwide.
Firm notified the public via: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
FDA event ID: 99930
Recall initiated: September 18, 2026
FDA classified: October 6, 2026
FDA report date: October 14, 2026

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Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 12:00 PM UTC. Record retrieved October 22, 2026 at 12:00 PM UTC.

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