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Showing 1–20 of 216 results

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Morphine Sulfate Solution (Winder) – Mispack Label Issue (2025)

Correct Labeled Product Mispack-Size stated on carton label did not match the size of the bottle in the carton.

FDANov 26, 2025Nationwide• Winder Laboratories, LLC

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Subpotent product:out of specification assay results observed during long term stability testing.

FDANov 26, 2025Nationwide• SOMERSET THERAPEUTICS LLC

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Subpotent product:out of specification assay results observed during long term stability testing.

Class III

FDANov 26, 2025Nationwide• SOMERSET THERAPEUTICS LLC

Cisatracurium Besylate Injection (Somerset) – Subpotent Product (2025)

Subpotent product:out of specification assay results observed during long term stability testing.

FDANov 26, 2025Nationwide• SOMERSET THERAPEUTICS LLC

Bisoprolol/Hydrochlorothiazide Tablets (Glenmark) – Cross Contamination (2025)

Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe

FDANov 21, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Nebivolol Tablets (Glenmark) – Cross Contamination (2025)

Cross Contamination with Other Products

FDANov 18, 2025Nationwide• Glenmark Pharmaceuticals Inc., USA

Varenicline Tablets (Dr. Reddy's) – Subpotent Drug (2025)

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

FDANov 11, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Heimishe Matjes Herring (Kosher First) – undeclared color (2025)

Undeclared Allergen

Undeclared FD&C Red #40

FDANov 10, 2025NY• Kosher First LLC

Pacific Seafood Raw Blackened Shrimp (Pacific Seafood) – Undeclared Sulfite (2025)

Undeclared Allergen

Undeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite.

FDANov 8, 2025AL, FL, IN +1 more• Pacific Seafood - Portland, LLC

Testosterone Gel 1% (Teva Pharmaceuticals) – leakage risk (2025)

Defective Container - A defect in the side-seal which allows leakage of product.

FDANov 7, 2025Nationwide• Teva Pharmaceuticals USA, Inc

Prenate Chewable Vitamin (Avion) – Undeclared Soy (2025)

Undeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in the product is listed as 250mg per serving instead of 250mcg per serving.

FDAOct 29, 2025AL, AZ, CA +14 more• Avion Pharmaceuticals, LLC

Klarity-C Drops (Imprimis) – Subpotent Medication (2025)

Subpotent Drug

FDAOct 20, 2025Nationwide• Imprimis NJOF, LLC

Everolimus Tablets (Endo) – impurity specification failure (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

Everolimus Tablets 2.5mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

Everolimus Tablets 5mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

Everolimus Tablets 10mg (Endo USA) – Impurity Specification (2025)

Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.

FDAOct 10, 2025Nationwide• Endo USA, Inc.

Fesoterodine Tablets (Alembic) – Impurity Levels (2025)

Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.

FDAOct 10, 2025Nationwide• Alembic Pharmaceuticals Limited

Ketamine HCl Injection (STAQ Pharma) – Labeling Issue (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

Hydromorphone HCL PF Injection (STAQ Pharma) – Labeling Error (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

FentaNYL Citrate PF Injection (STAQ Pharma) – Labeling Error (2025)

Labeling: Incorrect or Missing Lot and/or Exp Date

FDAOct 9, 2025Nationwide• STAQ Pharma, Inc.

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