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Verified · FDAClass II — Possible RiskMedications

Fosfomycin Tromethamine Granules for Oral Solution, , single-dose sachet Recall 2024

FOSFOMYCIN TROMETHAMINEIssued January 16, 2024Updated Reviewed by the Recall Watch editorial team

FOSFOMYCIN TROMETHAMINE Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laborato — recalled per FDA on 1/16/2024. Reason: Failed Impurities/Degradation Specification: Out of specification for organic impurities.

Agency
FDA
Issued
Jan 16, 2024
Brand
FOSFOMYCIN TROMETHAMINE
Distribution
1 states
Lots affected
20
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 January 16, 2024 · Last synced Apr 27, 2026

What's recalled

Fosfomycin Tromethamine Granules for Oral Solution, (equivalent to 3 grams of fosfomycin), single-dose sachet, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA. Distributed by: Ascend Laboratories, LLC. Parsippany, NJ 07054. NDC 67877-749-57

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Why it was recalled

Failed Impurities/Degradation Specification: Out of specification for organic impurities

Affected products & lot numbers
20 lots called out

Affected Lot Numbers

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

Lot Number
lOTS #: 22121458
22121459
22121460
22121461
22121462
22121463
22121464
Exp 4/2024
22121176
22121407
22121465
Exp 3/2024
22121761
22121762
22121763
22121764
22121766
22121968
22121969
Exp 5/2024.
Where was it sold
1 state

Nationwide in the USA

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 January 16, 2024. Do not use or consume the affected product.

What lot numbers are affected?

Affected lot numbers: lOTS #: 22121458, 22121459, 22121460, 22121461, 22121462, 22121463, 22121464, Exp 4/2024, 22121176, 22121407, 22121465, Exp 3/2024, 22121761, 22121762, 22121763, 22121764, 22121766, 22121968, 22121969, Exp 5/2024.. 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.