Alvogen Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications
Alvogen, Inc. is recalling 2,784 bottles of Nitrofurantoin Monohydrate/Macrocrystalline capsules because they failed to meet dissolution specifications.
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, and the hazard involves a failure to meet dissolution specifications, which is a quality defect rather than a direct physical injury risk like fire or choking.
Plain-English summary
Alvogen, Inc. is recalling 2,784 bottles of Nitrofurantoin Monohydrate/Macrocrystalline Capsules, 100 mg, 100-count bottles. The product is a prescription-only oral medication distributed nationwide and in Puerto Rico. The specific lot affected is #471976 with an expiration date of 03/2020.
The recall was initiated because the product failed to meet dissolution specifications. Dissolution testing ensures that the medication releases the active ingredient at the correct rate in the body. When this specification is not met, the medication may not work as intended.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for a replacement or alternative treatment. The product is identified by NDC 47781-303-01.
The recalled product
- Product
- NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE (NITROFURANTOIN MONOHYDRATE/MACROCRYSTALLINE)
- Brand
- NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALLINE
- Manufacturer
- Alvogen, Inc
- Category
- Drug — Antibiotic
- Hazard
- Affected units
- 2,784
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 (2)
- Lot # 471976
- Exp 03/2020
UPCs (1)
- 0347781303013
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Alvogen, 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
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