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Takeda Pharmaceuticals North America, Inc.

Takeda Pharmaceuticals North America, Inc. Recalls

All product recalls associated with Takeda Pharmaceuticals North America, Inc..

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Recall Summary

Total Recalls

1000

Past Year

303

Class I (Serious)

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 3061–3080 of 4747 recalls

CONTRAVE (Takeda) – Tablet Defect Risk (2015)

Failed Tablet/Capsule Specifications: Potential tablet defect of broken tablets and/or equatorial splitting of the bilayer tablets into the two drug components.

Class IIModerate

FDAMay 21, 2015Nationwide• Takeda Pharmaceuticals North America, Inc.

Fentanyl Citrate Injection (West-Ward) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications; 12 month stability testing (Expansion of RES #70548).

Class IIILow

FDAMay 13, 2015Nationwide• West-Ward Pharmaceutical Corp.

Zebeta Tablets (Teva) – Dissolution Specification Failure (2015)

Failed Dissolution Specifications: OOS result during stability testing

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Class IIModerate

FDAMay 11, 2015Nationwide• Teva Pharmaceuticals USA

QVAR Inhalation Aerosol (Teva) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: out of specification test results for an impurity during stability testing.

Class IIILow

FDAMay 7, 2015Nationwide• Teva Pharmaceuticals USA

Ortho-Cept Birth Control (Janssen) – Subpotent Medication (2015)

Subpotent Drug

Class IIModerate

FDAApr 29, 2015Nationwide• Janssen Pharmaceuticals, Inc.

Azithromycin 250mg Tablets (PD-Rx) – CGMP Manufacturing Issue (2015)

cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 29, 2015Nationwide• PD-Rx Pharmaceuticals, Inc.

Azithromycin 500mg Tablets (PD-Rx) – CGMP Manufacturing Issue (2015)

cGMP Deviations: This recall is a result of the original manufacturer's recall, in which the firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 29, 2015Nationwide• PD-Rx Pharmaceuticals, Inc.

Phenylephrine Sodium Chloride (SCA) – Labeling Mix-Up (2015)

Labeling: Label Mix-Up: Product is incorrectly labeled as phenylephrine 50 mg in 0.9% sodium chloride rather than phenylephrine 50 mg in 5% dextrose.

Class IIModerate

FDAApr 28, 2015CA• SCA Pharmaceuticals

Adrucil Injection (Teva) – Particulate Matter Contamination (2015)

Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Class IHigh

FDAApr 28, 2015Nationwide• Teva Pharmaceuticals USA

Chlordiazepoxide/Clidinium Capsules (Valeant) – Impurity Specs (2015)

Failed Impurities/Degradation Specifications

Class IIILow

FDAApr 18, 2015Nationwide• Valeant Pharmaceuticals North America LLC

Librax Capsules (Valeant) – Impurity Specs (2015)

Failed Impurities/Degradation Specifications

Class IIILow

FDAApr 18, 2015Nationwide• Valeant Pharmaceuticals North America LLC

Nifedipine Extended-Release Tablets (Valeant) – Dissolution Failure (2015)

Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Class IIModerate

FDAApr 17, 2015Nationwide• Valeant Pharmaceuticals North America LLC

Fluoxetine Capsules 20mg (Teva) – Chemical Contamination (2015)

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

Class IIModerate

FDAApr 13, 2015Nationwide• Teva Pharmaceuticals USA

Fluoxetine Capsules 10mg (Teva) – Chemical Contamination (2015)

Chemical Contamination: Product recalled due to an elevated level of a residual solvent impurity in the API that exceeds the Threshold of Toxicological Concern (TTC) calculation for the impurity.

Class IIModerate

FDAApr 13, 2015Nationwide• Teva Pharmaceuticals USA

Promethazine Codeine Syrup (Qualitest) – Impurity Concern (2015)

Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.

Class IIILow

FDAMar 25, 2015Nationwide• Qualitest Pharmaceuticals

Glipizide Metformin Tablets (Heritage) – Unknown Impurity (2015)

Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.

Class IIModerate

FDAMar 25, 2015Nationwide• Heritage Pharmaceuticals, Inc.

Fexofenadine HCl Tablets (Mylan) – Impurity Concern (2015)

Failed Impurities/Degradation Specifications: out of specification results for a related compound - a degradant of fexofenadine.

Class IIILow

FDAMar 11, 2015Nationwide• Mylan Pharmaceuticals Inc.

Ergoloid Mesylates (Mutual Pharmaceutical) – Impurity Specification Failure (2015)

Failed Impurities/Degradation Specifications: during long-term stability testing.

Class IIModerate

FDAMar 10, 2015Nationwide• Mutual Pharmaceutical Company, Inc.

Domperidone BP Ingredient (Freedom Pharmaceuticals) – Penicillin Risk (2015)

Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.

Class IIModerate

FDAMar 10, 2015Nationwide• Freedom Pharmaceuticals Inc

ASN Products (James G. Cole) – court-ordered product withdrawal (2015)

All ASN brand products are recalled because it was ordered by the United States District Court for the District of Oregon. Products are also recalled due to misbranded, adulterated, and unapproved new drugs because of certain claims about their effects had not been approved by the FDA.

Class IIModerate

FDAMar 6, 2015Nationwide• James G. Cole, Inc., dba ASN/Maxam Neutraceutics