FDA Recalls Nitrofurantoin Capsules Due to Failed Dissolution Specifications
Sun Pharmaceutical recalls Nitrofurantoin Capsules (100 mg) due to failed dissolution, affecting medication effectiveness. The recall involves 5,752 bottles nationwide in lots 231067 and 231069.
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 3/5 (High).
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: This is a High severity recall because it involves a Class II manufacturing defect affecting drug efficacy. Per the severity rubric, theoretical product hazards without reported illnesses are limited to High severity, which applies here.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Nitrofurantoin Capsules, USP (Macrocrystals), 100 mg, due to failed dissolution specifications. The recall affects 5,752 bottles distributed nationwide in the United States and Puerto Rico.
The capsules failed to meet dissolution specifications, which means they may not dissolve properly in the body. This could reduce the medication's effectiveness in treating urinary tract infections.
The affected products are lot numbers 231067 and 231069, with expiration date of 04/30/2025. The product contains NDC 57664-233-88 and was manufactured by Sidmak Laboratories in Dehradun, India, and distributed from Sun Pharmaceutical's facility in Cranbury, New Jersey.
Consumers who have purchased this medication should stop taking it and consult their healthcare provider. Patients should speak with their pharmacist or doctor about alternative treatments.
The recalled product
- Product
- NITROFURANTION (NITROFURANTION)
- Brand
- NITROFURANTION
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Antibiotic / Oral Capsule
- Hazard
- Affected units
- 5,752
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 #s: 231067
- 231069
- Exp 04/30/2025
UPCs (3)
- 0357664232187
- 0357664233184
- 0357664231180
Distribution
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