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Showing 261–280 of 505 results

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Duloxetine Capsules (Breckenridge) – CGMP Impurity (2025)

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class IIModerate

FDAJun 30, 2025Nationwide• Breckenridge Pharmaceutical, Inc.

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class IIModerate

FDAJun 30, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Budesonide Inhalation Suspension (Cipla) – Sterility Issue (2025)

Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.

Class IIModerate

FDAJun 30, 2025Nationwide• Cipla USA, Inc.

Penicillin G Potassium (Sandoz) – Labeling Mix-Up (2025)

Labeling: Label Mix-Up; Some vials of Cefazolin for Injection, USP 1 gram were incorrectly labeled as penicillin G potassium for Injection, USP, 20 million Unit

FDAJun 27, 2025Nationwide• Sandoz Inc

Cefazolin Injection (Sandoz) – Labeling Mix-Up (2025)

Labeling: Label Mix-Up; cartons of Cefazolin for Injection, USP 1 gram were found to contain vials labeled as penicillin G potassium for Injection, USP, 20 million Unit. The vials contained Cefozalin

FDAJun 27, 2025Nationwide• Sandoz Inc

Pitavastatin Tablets 1mg (AvKARE) – Impurity Specification Failure (2025)

Failed Impurity/Degradation Specifications

FDAJun 26, 2025Nationwide• AvKARE

Iron Supplements (iHerb) – Potential Contamination (2025)

This recall involves three types of California Gold Nutrition dietary supplements: Daily Prenatal Multi, Ultamins Women's Multivitamin, and Ultamins Women's 50+ Multivitamin. The California Gold Nutrition Daily Prenatal Multivitamin bottles are white with a white lid and a gold border label. The bottle contains 60 fish gelatin softgel dietary supplements. The California Gold Nutrition Women's Multivitamin and Women's 50+ Multivitamin both have dark purple packaging with a gold border label. Both products contain 60 capsules in foil within the packaging. The following batch numbers and expiration dates for the products are printed on the back of the package near the bottom of package/sleeve. Products Batch Codes Expiration Dates Daily Prenatal Multi 2307050A, 2404096A, 2411100A 08/2025, 05/2026, 11/2026 Ultamins Women's Multivitamin V0532, V0533 11/2026, 07/2026 Ultamins Women's 50+ Multivitamin V0534, V0536 07/2026, 11/2026

CPSCJun 26, 2025Nationwide• iHerb LLC, dba Madre Labs LLC, of Irvine, California

Pitavastatin Tablets 2mg (AvKARE) – Impurity Specification Failure (2025)

Failed Impurity/Degradation Specifications

FDAJun 26, 2025Nationwide• AvKARE

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Downstream recall of a dietary supplement ingredient that was manufactured out of specifications.

FDAJun 24, 2025CA, IN, OK• GMP Laboratories of America Inc

Metoprolol Succinate Tablets 25mg (Granules) – Dissolution Specification Failure (2025)

Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the stability studies at the 6th month (25¿C/60% RH) long-term.

Class IIModerate

FDAJun 24, 2025Nationwide• Granules Pharmaceuticals Inc.

Lithium Orotate Capsules (GMP Laboratories) – Manufacturing Specification (2025)

Downstream recall of a dietary supplement ingredient that was manufactured out of specification.

FDAJun 24, 2025CA, IN, OK• GMP Laboratories of America Inc

Levothyroxine Sodium Tablets 150mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 50mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Lisinopril/Hydrochlorothiazide Tablets (Lupin) – Product Mix-Up (2025)

Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.

Class IIModerate

FDAJun 20, 2025Nationwide• Lupin Pharmaceuticals Inc.

Levothyroxine Sodium Tablets 175mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 112mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 25mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 25mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Levothyroxine Sodium Tablets 100mcg (Accord) – Subpotent Drug (2025)

Subpotent Drug: Assay below the approved specification

Class IIModerate

FDAJun 20, 2025Nationwide• ACCORD HEALTHCARE, INC.

Gabapentin Capsules 100mg (Harvard Drug) – Defective Container (2025)

Defective container; blister packaging inadequately sealed.

Class IIModerate

FDAJun 19, 2025Nationwide• The Harvard Drug Group LLC

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