Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Nitrofurantoin Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
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.
Affected NDC
50268-0625-15
Compare with the code on your package — it is the most precise check available.
Drug: Nitrofurantoin
- Recalling firm
- AvKARE
- Origin
- TN, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0168-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Nitrofurantoin recalls
See all
Class III · Low risk
Nitrofurantoin Capsules
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Class II · Moderate risk
Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only…
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Nitrofurantoin Capsules USP
Failed Dissolution Specifications
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrycrystals Capsules
Failed dissolution specifications
Other recalls by AvKARE
All 2024 recalls
Class II · Moderate risk
Amantadine HCl
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II · Moderate risk
Rosuvastatin Tablets
Out of specification for dissolution.
Class II · Moderate risk
Norgestimate and Ethinyl Estradiol Tablets
Failed Content Uniformity Specifications
Class II · Moderate risk
chloroproMAZINE Hydrochloride Tablets
Presence of a foreign substance.
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