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Class II · ModerateRecall completed

Neomycin Sulfate

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: 3007830, 3007746, 3007829, Exp. Date 10/2024
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: A foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used in the manufacture of Neomycin Sulfate Tablets, USP 500 mg.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byTeva Pharmaceuticals USA, Inc.
Brand nameNEOMYCIN SULFATE
Generic nameNEOMYCIN SULFATE
Active ingredient(s)NEOMYCIN SULFATE
Distributed by / forTEVA PHARMACEUTICALS USA, INC North Wales, PA 19454
NDC0093-1177-01
Show the full FDA record
Full product labelNeomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01
Recalling firmTeva Pharmaceuticals USA Inc
DistributionNationwide within the United States
Recall initiated2022-08-23
Report date2022-09-07
Recall completed2023-09-07
Recall numberD-1473-2022
ClassificationClass II
FDA statusTerminated
Origin on fileParsippany NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.