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.
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water…
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Presence of Particulate Matter: filmy/cloudy particulate observed in vial.
Subpotent
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
CGMP Deviations: Out of specification test result observed during retrospective review of blend uniformity test data.
Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil
Discoloration: Market complaints of discoloration in Moxifloxacin Ophthalmic Solution.
Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS)
Failed Impurities/Degradation Specifications; out-of-specification results obtained for related substance.
cGMP Deviations; released lots were manufactured under similar manufacturing conditions to a previously rejected OOS Lot.
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
Labeling Product Contains Undeclared API: Active Ingredient on label is not the active ingredient in the product.
CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two…
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.
