AvKARE Nitrofurantoin 100 mg Capsules Recalled for Dissolution Failures
AvKARE is recalling Nitrofurantoin 100 mg capsules (NDC 50268-625-15, lot 47101, exp. 02/2026) nationwide because they failed dissolution specifications. Affected users should consult their healthcare provider.
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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard is a medication quality and efficacy issue (failed dissolution specifications) rather than a direct contamination or safety hazard. This fits the classification of a precautionary or quality-focused recall without reported harm.
Plain-English summary
AvKARE, Inc. is recalling Nitrofurantoin Capsules, USP, 100 mg supplied in unit dose cartons (50 capsules per carton). The recall involves approximately 1,016 cartons with NDC number 50268-625-15, lot number 47101, and expiration date 02/2026 that were distributed nationwide.
The recalled capsules were found to have failed dissolution specifications. Dissolution specifications ensure the medication properly dissolves and releases in the body.
The recall affects patients who received prescriptions of this medication from the affected lot. Healthcare providers and pharmacists should identify and remove affected product from inventory.
Patients or healthcare providers who have the recalled product should contact their pharmacy or healthcare provider to discuss medication replacement options and any concerns about prior doses.
The recalled product
- Product
- Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.
- Manufacturer
- AvKARE
- Category
- Drug — Antibiotic
- Hazard
- dissolution-failure
- medication-efficacy
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 # 47101
- Exp. 02/2026
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereErythromycin Tablets Recalled for Impurity Above Acceptable Limits
FDA (Drugs) · 2026-05-27
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27