Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Assurance of Sterility: Potential leaks from perforations in bags.
CGMP Deviations: Presence of N-nitroso-Duloxetine impurity above FDA recommended limit of 0.83 ppm, identified at the 12-month and 18-month long-term stability intervals.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
This recall is being conducted due to out of specification assay results in a limited number of bottles that were stored on side.
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Labeling: Incorrect or Missing Lot and/or Exp Date:The expiration date has an extra digit and is printed as 2709114 instead of the correct 270914 (2027-09-14). It is important to note that…
Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin
Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
Defective container: defect in a batch of bottle caps, specifically involving dislodged or missing cap liners.
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
Failed Viscosity Specifications: Out of Specification results, above the specification limit, in viscosity, noted during stability testing.
This recall is being initiated following FDA's recommendation based on certain observations noted during an August 15, 2025, inspection of the manufacturing facility that may bear on…
A drug recall record can include the reason for recall, firm, status, distribution pattern, quantity and FDA classification. This site does not provide medical advice; it organizes public recall information and links users back to official sources.
Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.
This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.
