Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Nitrofurantoin Oral Suspension Recalled by LUPIN SOMERSET Due to Subpotent Drug: Expansion of June 2018 recall of...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact LUPIN SOMERSET directly.
Affected Products
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, NDC 43386-450-11.
Quantity: 23,460 bottles
Why Was This Recalled?
Subpotent Drug: Expansion of June 2018 recall of lots S700065 and S700619 due to below specification results for assay.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About LUPIN SOMERSET
LUPIN SOMERSET has 13 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report