The Recall Desk
ModerateFDA (Drugs)·D-0346-2019·Announced 2019-01-09

Lupin Recalls Subpotent Nitrofurantoin Oral Suspension Lots

Lupin Pharmaceuticals is recalling specific lots of Nitrofurantoin Oral Suspension because the drug was found to contain less active ingredient than required.

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 recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The hazard is a subpotent drug (below specification for assay), which is a quality issue rather than a contamination or acute safety hazard like a foreign object or toxic substance.

Plain-English summary

Lupin Pharmaceuticals, Inc. is recalling 23,460 bottles of Nitrofurantoin Oral Suspension, USP, 25mg/5mL, 230 mL. The recall is an expansion of a previous recall from June 2018 and includes specific lots identified by the manufacturer as having below-specification results for assay, meaning the medication contains less of the active ingredient than it should.

The affected product is a prescription-only medication manufactured by Novel Laboratories, Inc., for Lupin Pharmaceuticals, Inc. The recall covers lots S700038, S700044, S700059, S700065, S700410, S700427, S700617, S700619, S700813, S700815, S700869, S700871, S700873, S700875, and S701073. These products were distributed nationwide in the USA and Puerto Rico.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If the product matches the recalled lots, it should be discontinued and returned to the supplier or disposed of according to local regulations. Patients should consult their healthcare provider for alternative treatment options if they have been prescribed the affected medication.

The recalled product

Product
NITROFURANTOIN (NITROFURANTOIN)
Brand
NITROFURANTOIN
Manufacturer
LUPIN SOMERSET
Category
Drug — Antibiotic
Hazard
Affected units
23,460

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 (20)

  • Lot #: S700038
  • S700044
  • S700059
  • S700065
  • Exp 28-Feb-19
  • S700410
  • S700427
  • Exp 30-Jun-19
  • S700617
  • S700619
  • Exp 31-Aug-19
  • S700813
  • S700815
  • S700869
  • Exp 31-Oct-19
  • S700871
  • S700873
  • Exp 30-Nov-19
  • S700875
  • S701073

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Related recalls

Same brand · NITROFURANTOIN

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