12 FDA recalls mention Naproxen. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Naproxen.
Reason Chemical contamination; presence of lead and lithium above specification
Reason CGMP Deviations
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium…
Reason Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree…
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Reason Labeling: Label Mix-Up: Bottles labeled as Naproxen Tablets USP, 500 mg, 100-count may contain 90-count Pravastatin Sodium Tablets, 40 mg.
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