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Fosfomycin Tromethamine Granules for Oral Solution, , 1 Single-Dose Sachet Recall 2026

FOSFOMYCIN TROMETHAMINEIssued September 18, 2026Updated Reviewed by the Recall Watch editorial team

FOSFOMYCIN TROMETHAMINE 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 — recalled per FDA on 9/18/2026. Reason: Failed Impurities/Degradation Specifications.

Agency
FDA
Issued
Sep 18, 2026
Brand
FOSFOMYCIN TROMETHAMINE
Distribution
1 states
Lots affected
2
What to do right now

Steps to take for this recall

  1. Stop using it

    Take it out of rotation. Don't consume, wear, or operate.

  2. Verify the match

    Compare lot numbers, UPCs, and dates against your product.

  3. Return or dispose

    Follow the manufacturer's instructions to refund or safely dispose.

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Verified summary of the official U.S. Food and Drug Administration notice · Issued September 18, 2026 · Last synced Oct 21, 2026

What's recalled

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.

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Why it was recalled

Failed Impurities/Degradation Specifications

Affected products & lot numbers
2 lots called out

Affected Lot Numbers

Check your product label — do not use if your lot number appears below.

Lot Number
Lot#: 5KA0405
Exp 12/31/2026.
Where was it sold
1 state

USA Nationwide.

nationwide
Official noticefda.gov
More recalls like this
5 related — by brand, contaminant, and category

Frequently asked questions

Is the FOSFOMYCIN TROMETHAMINE recall still active?

Yes, this recall is currently active as of September 18, 2026. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: Lot#: 5KA0405, Exp 12/31/2026.. Check the label on your product.

What should I do if I have the recalled FOSFOMYCIN TROMETHAMINE?

Do not consume or use this product. Return it to the store for a full refund, or dispose of it safely.