The Recall Desk
ModerateFDA (Drugs)·D-0011-2016·Announced 2015-10-21

Boehringer Ingelheim Roxane Recalls Furosemide Tablets Due to CGMP Deviations

Boehringer Ingelheim Roxane Inc. is recalling furosemide tablets USP because the wrong active pharmaceutical ingredient was used during manufacturing.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves a manufacturing error (wrong API) rather than a high-risk pathogen or structural defect, fitting the Moderate severity criteria for low-risk contamination or labeling/manufacturing errors without reported illness.

Plain-English summary

Boehringer Ingelheim Roxane Inc. is recalling 11,110 bottles of FUROSEMIDE Tablets USP, 20 mg, 1000-count. The affected product is distributed nationwide and in Puerto Rico. The specific lots involved are 559660P and 559661P, with an expiration date of 03/17.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP. This manufacturing error resulted in the tablets containing the incorrect formulation.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product matches the recalled description, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they have been using the recalled product.

The recalled product

Product
FUROSEMIDE (FUROSEMIDE)
Brand
FUROSEMIDE
Manufacturer
Boehringer Ingelheim Roxane Inc
Category
Drug — Prescription Drug
Hazard
Affected units
11,110

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 (3)

  • Lot #: 559660P
  • 559661P
  • Exp 03/17

UPCs (5)

  • 0300544301251
  • 0300544299251
  • 0300544297257
  • 0300543298637
  • 300544297318

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Boehringer Ingelheim Roxane Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same brand · FUROSEMIDE

Same manufacturer · Boehringer Ingelheim Roxane Inc

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Same hazard · manufacturing error

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