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 or Missing Lot and/or Exp Date: Product incorrectly labeled with an expiration date of August 2022 rather than the correct expiration date of April 2022.
Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.
Defective Container: confirmed customer reports for vials with loose metal overseal crimp defects, which may result in lack of assurance of sterility.
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture…
Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture…
Failed Dissolution Specifications: Low out of specification results obtained during stability testing.
Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
Labeling: Label Lacks Warning: Product recalled due to absence of a warning statement on the product label, Ask a doctor before use if you have a sodium-restricted diet.
cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container…
CGMP Deviations: Presence of NDMA impurity detected in product.
GMP Deviations: Product bottle may be absent of desiccant.
Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium…
CGMP Deviations: Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
Failed Dissolution Specifications: low out of specification results for dissolution testing.
GMP Deviations: Product bottle may be absent of desiccant.
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Subpotent: Out of specification for assay at the 12-month time point.
Presence of Particulate Matter: Particulates observed in vials release for dispensing.
Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
CGMP Deviations: Trace amounts of an impurity, N-nitrosodimethylamine (NDMA) was detected in the API Nizatidine.
CGMP Deviations: Presence of NDMA impurity detected in product.
CGMP Deviations: Presence of NDMA impurity detected in product.
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.
