Lupin Recalls Nitrofurantoin Oral Suspension Due to Subpotent Drug
Lupin Pharmaceuticals is recalling Nitrofurantoin Oral Suspension because the drug is subpotent and failed content uniformity testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 is reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard is a subpotent drug, which is a quality issue rather than a direct physical injury risk like a foreign object or high-risk pathogen.
Plain-English summary
Lupin Pharmaceuticals, Inc. is recalling Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle. The product was manufactured by Novel Laboratories, Inc. and distributed nationwide within the US. The recall involves 3,456 cartons.
The recall was initiated because the drug is subpotent and failed content uniformity testing. This means the medication may not contain the correct amount of the active ingredient, potentially rendering it ineffective for treating urinary tract infections.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for a replacement. The affected lots are S700065 (Exp. 02/2019) and 700619 (Exp. 08/2019). The product is identified by NDC 43386-450-11 and UPC 343386-450-114.
The recalled product
- Product
- NITROFURANTOIN (NITROFURANTOIN)
- Brand
- NITROFURANTOIN
- Manufacturer
- LUPIN SOMERSET
- Category
- Drug — Antibiotic
- Affected units
- 3,456
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#: S700065
- Exp. 02/2019
- 700619
- Exp. 08/2019
UPCs (1)
- 343386450114
Distribution
Distributed nationwide across the United States.
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