Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated Jun 28, 2018 (8 years ago)

Nitrofurantoin Oral Suspension USP

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Subpotent Drug and Failed Content Uniformity.

Cause type: Wrong potency / content

Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.

What was recalled

Nitrofurantoin Oral Suspension USP, 25mg/5mL, 230 mL Bottle, Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, UPC 343386-450-114, NDC 43386-450-11

Affected NDC 43386-0450-11

Compare with the code on your package — it is the most precise check available.

Drug: Nitrofurantoin

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Nitrofurantoin
NDC 43386-0450		 25 mg/5mL Suspension
Oral		 Lupin Pharmaceuticals,Inc. Rx
Recalling firm
Lupin Somerset
NDC code
43386-450-11
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0927-2018 · 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

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.

Terminated Dissolution failure American Health Packaging NDC 68084-446-11 D-0880-2022

Other recalls by Lupin Somerset

All 2018 recalls