Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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FDA Drug Recalls

34 recalls, newest first

Risk Class IClass IIClass III
Status OngoingCompletedTerminated
Year 20262025202420232022 2011 All years
Cause Sterility / contaminationNitrosamine impurityChemical / undeclaredParticulate / foreign matterLabeling / mix-upcGMP deviationMicrobial contamination All causes
Class I · High risk

Actra-SX 500 Capsules

Marketed without an Approved NDA/ANDA; product contains sildenafil, an active ingredient in a FDA approved product for the treatment of Erectile Dysfunction

Terminated Chemical / undeclared Body Basics Inc D-265-2013
Class I · High risk

Argatroban Injection 50 mg per 50ml

A complaint was received from a hospital pharmacy on 11/10/11 for crystalline particulates in a single vial from Lot V10194. Additional small visible particles consisting of fibers were identified.

Terminated Particulate / foreign matter Eagle Pharmaceuticals Inc. NDC 42367-203-07 D-1429-2012
Class II · Moderate risk

ChloraPrep with Tint

Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.

Terminated Sterility / contamination Carefusion 213, Llc D-1674-2012
Class II · Moderate risk

Prefera OB One Gel Capsules

Labeling: Presence of Undeclared Color Additive; The product is being recalled because several inactive ingredients were not included in the labeling for this product: Undeclared D&C Red #33, FD&C Blue #1, Titanium Dioxide Suspension, Purified Water USP.

Terminated Labeling / mix-up Meda Pharmaceuticals Inc. NDC 68220-086-30 D-1418-2012
Class II · Moderate risk

Xactdose Phenytoin Oral Suspension

Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.

Terminated Wrong potency / content VistaPharm, Inc. NDC 66689-036-50 D-1440-2012
Class II · Moderate risk

Docusate Calcium Softgel Capsules

Labeling: Label Mix up; product labeled to contain Docusate Sodium 240mg instead of Docusate Calcium 240mg

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 00904-5779-60 D-1451-2014
Class II · Moderate risk

Sulfamethoxazole and Trimethoprim Tablets

Labeling: Label Mix up; product labeled to contain Sulfamethoxazole and Trimethoprim Tablets, 400 mg/80 mg instead of Sulfamethoxazole and Trimethoprim Tablets, 800 mg/160 mg

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-272-01 D-1450-2014
Class II · Moderate risk

Pramipexole Dihydrochloride Tablets

Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 16714-586-01 D-1449-2014
Class I · High risk

metFORMIN ER Tablets

Labeling: Label Mix up; product labeled did not indicated Extended Release

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 53746-178-01 D-1448-2014
Class I · High risk

Oxycodone HCl Oral Concentrate

Labeling: Label Mix up; product labeled as Morphine Sulfate 20 mg/mL actually contained OxyCODONE HCl 20 mg/mL

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 00527-1426-36 D-1447-2014
Class I · High risk

Taztia XT (Diltiazem HCl)

Labeling: Label Mix Up; packages labeled as Thiamine actually contain Diltiazem Capsules

Terminated Labeling / mix-up Shamrock Medical Solutions Group LLC NDC 62037-0696-90 D-1446-2014
Class II · Moderate risk

Arthrotec 75

Tablet Separation: The manufacturer of Arthrotec had recalled the lots that were used to re-package this product because they may contain broken tablets.

Terminated Failed specification Physicians Total Care, Inc. NDC 54868-4165-1 D-1379-2012
Class II · Moderate risk

Murocel (methylcellulose)

Lack of Assurance of Sterility: Bausch & Lomb, Inc. is recalling 7 Lots of Murocel Methylcellulose Lubricant Opthalmic Solution 1% (15 mL). Product was found to be OOS for Antimicrobial Effectiveness testing (AET) at the 12 month stability time point.

Terminated Sterility / contamination Bausch & Lomb, Inc. NDC 24208-280-15 D-1370-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-552-01 D-1375-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-553-01 D-1374-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-555-01 D-1373-2012
Class II · Moderate risk

Daytrana (methylphenidate)

Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Terminated Packaging defect Noven Pharmaceuticals, Inc. NDC 54092-554-30 D-1372-2012
Class III · Low risk

Azelastine HCl Nasal Solution

CGMP Deviations: tubing used for filling may interact with the nasal formulation of this product.

Terminated cGMP deviation Apotex Corp. NDC 60505-0833-5 D-1667-2012
Class III · Low risk

Percocet 10/325 mg tablets

Presence of Foreign Tablets/Capsules: One bottle of Percocet 10/325 mg was found to contain a tablet of Endocet 10/25 mg, the generic form.

Terminated Particulate / foreign matter Physicians Total Care, Inc. NDC 54868-4710-0 D-301-2013

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