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.
Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Presence of Particulate Matter: Piece of metal found in a vial
Lack of Assurance of Sterility: environmental monitoring failure.
GMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Presence of Particulate Matter: A complaint was received for the presence of a hair in one vial.
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
Presence of Particulate Matter: A complaint was received for the presence of a single strand of hair in one vial.
Incorrect Product Formulation: Oxytocin 30 units was added to an IV bag of 0.45% Sodium Chloride (500mL) instead of 0.9% Sodium Chloride (500mL).
Superpotent Drug: Out of specification for assay at the 12-month timepoint.
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Lack of Assurance of Sterility
Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
Product mix-up:0.2 mg strength Clonidine Hydrochloride Tablets, USP in a 100-count bottle of 0.3 mg strength Clonidine Hydrochloride Tablets,
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Microbial contamination of non-sterile products.
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Presence of particulate matter
Microbial contamination of non-sterile products.
Lack of Assurance of Sterility
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.
