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Showing 1–20 of 249 results

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Lifted Made-Lemon Tablet (Eden's Elixirs) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Mint Flavored Tablets (Eskay Brands) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Mint Flavored Tablets (Lifted Made) – Undeclared Yellow #5 (2025)

Undeclared Allergen

Undeclared Yellow #5

Class IIModerate

FDASep 9, 2025IN, TX• Eden¿¿¿s Elixirs, LLC

Fluoxetine Tablets (Torrent Pharma) - CGMP Nitrosamine Deviation (2025)

CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.

Class II

FDAMay 27, 2025Nationwide• Torrent Pharma Inc.

Irbesartan Tablets 300mg (AvKARE) – Dissolution Issue (2025)

Out of Specification for Dissolution

Class II

FDAJan 21, 2025Nationwide• AvKARE

Calcium Carbonate Chewable (Safecor Health) – Packaging Defect (2024)

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Class II

FDANov 11, 2024Nationwide• Safecor Health, LLC

Ultra T-MALE Testosterone Boost (NaturesPlus) – ingredient mismatch (2024)

Product is missing the ingredient TongKat Ali and has additional Rhodiola Rosea

Class III

FDAMay 31, 2024Nationwide• Natural Organics, Inc.

Methylfolate Chewables (Bluebonnet) – Label Error (2024)

Label error during reprint. Says 1000 mg instead of 1000 mcg on the center front panel of the label.

Class III

FDAJan 12, 2024Nationwide• Bluebonnet Nutrition Corporation (Dairy Ashford)

Neptune's Fix Tianeptine Tablets (Neptune Resources) – Unapproved Drug (2024)

Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved for any medical use in the United States.

Class I

FDAJan 12, 2024Nationwide• Neptune Resources, LLC

Pyrazinamide Tablet 500mg (RemedyRepack) – Quality Program Issue (2023)

CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.

Class II

FDAMay 1, 2023IN, PA• RemedyRepack Inc.