Class II · Moderate risk Ongoing
Naproxen Oral Suspension
Reason Chemical contamination; presence of lead and lithium above specification
Is Naproxen recalled?
Yes — there is an active recall. 4 ongoing FDA recalls mention Naproxen (12 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Naproxen. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Ongoing
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Naproxen Tablets
Reason Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodium Tablets
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodum Tablets USP 220 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Naproxen Sodium active pharmaceutical ingredient packaged in…
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 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 Terminated
Naproxen Base active pharmaceutical ingredient packaged in…
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 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 Terminated
Assured Naproxen Sodium Tablets
Reason Correct Labeled Product Mispacked; correct labeled bottles of Assured Ibuprofen softgels were packaged into cartons of Assured Naproxen Sodium Tablets, USP
Class II · Moderate risk Terminated
Naproxen
Reason Labeling: Label Mixup; NAPROXEN, Tablet, 500 mg may be potentially mislabeled as THIOTHIXENE, Capsule, 1 mg, NDC 00378100101, Pedigree: AD54549_22, EXP: 5/20/2014; HYDROCHLOROTHIAZIDE, Tablet, 12.5 mg, NDC 00228282011, Pedigree: AD67989_13, EXP: 5/28/2014.
Class II · Moderate risk Ongoing
Naproxen 100 mg/ml Injection
Reason Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II · Moderate risk Terminated
Naproxen Tablets USP
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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