The Recall Desk
HighFDA (Drugs)·D-1473-2022·Announced 2022-09-07

Prescription Antibiotic Tablets Recalled for Foreign Matter in Active Ingredient

Teva Pharmaceuticals is recalling Neomycin Sulfate Tablets because teflon was found in the active ingredient. Affected lot numbers: 3007830, 3007746, 3007829.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Foreign material contamination in a prescription drug's active pharmaceutical ingredient represents a risk-of-harm product where injury has not yet been reported. No illnesses or injuries have been documented.

Plain-English summary

Teva Pharmaceuticals USA Inc. is recalling Neomycin Sulfate Tablets, USP 500 mg in 100-count bottles because foreign matter identified as teflon was found in the Active Pharmaceutical Ingredient (API) used to manufacture the product. This represents a Current Good Manufacturing Practice (CGMP) deviation.

The recalled medication has lot numbers 3007830, 3007746, and 3007829, with an expiration date of 10/2024. The product was distributed nationwide within the United States.

Patients currently taking this medication from the recalled lots should contact their healthcare provider before discontinuing use. Do not use the product if you have one of the affected lot numbers. Consumers with questions should contact their healthcare provider or the FDA.

The recalled product

Product
NEOMYCIN SULFATE (NEOMYCIN SULFATE)
Brand
NEOMYCIN SULFATE
Manufacturer
Teva Pharmaceuticals USA Inc
Category
Drug
Hazard
  • foreign-matter
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot #: 3007830
  • 3007746
  • 3007829
  • Exp. Date 10/2024

UPCs (1)

  • 0300931177018

Distribution

Distributed nationwide across the United States.