Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
Is Nitrofurantoin recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Nitrofurantoin (17 total). Check the affected lots below.
Most common reason: Dissolution failure (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Nitrofurantoin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Nitrofurantoin recalls on record
none so far in 2026; 17 on record, newest first
Class II · Moderate risk
Nitrofurantoin Capsules
Failed Dissolution Specifications
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
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Class III · Low risk
Nitrofurantoin Capsules USP
Cross contamination with other products: This sub-recall is being initiated in support of the recall by the manufacturer (Sandoz) dated 11/1/18, which included lots that were repackaged by American Health Packaging. Sandoz stated that "These lots are being recalled due to the potential presence of unrelated ingredients (i.e. traces of active ingredients of Benazepril, Haloperidol and Perphenazine), which were identified through a manufacturing investigation."
Class III · Low risk
Nitrofurantoin Monohydrate/Macrocrystals capsules
Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
Class III · Low risk
Nitrofurantoin Capsules
Cross Contamination with Other Products
Class III · Low risk
Nitrofurantoin Capsules
Cross Contamination with Other Products
Class II · Moderate risk
Nitrofurantoin Oral Suspension USP
Subpotent Drug and Failed Content Uniformity.
Class II · Moderate risk
Nitrofurantoin Oral Suspension
Failed Dissolution Specifications
Class II · Moderate risk
Nitrofurantoin Monohydrate/Macrocrystals Capsules
Failed Dissolution Specification; 6 month time point
Class II · Moderate risk
Nitrofurantoin active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
NITROFURANTOIN MACROCRYSTALS Capsule
Labeling: Label Mixup; NITROFURANTOIN MACROCRYSTALS Capsule, 50 mg may be potentially mislabeled as PHYTONADIONE, Tablet, 5 mg, NDC 25010040515, Pedigree: AD25452_1, EXP: 4/30/2014.
Class II · Moderate risk
NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS Capsule
Labeling: Label Mixup; NITROFURANTOIN MONOHYDRATE/ MACROCRYSTALS, Capsule, 100 mg may be potentially mislabeled as MINOCYCLINE HCL, Capsule, 50 mg, NDC 00591569401, Pedigree: AD52778_46, EXP: 5/20/2014.
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