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.
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
CGMP Deviations: active ingredient may be subpotent before the labeled expiry due to degradation.
Failed Dissolution Specifications: Out of specification dissolution results above specified values.
Labeling; Incorrect NDC number on outer carton of product.
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is February 2025.
Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
CGMP Deviations: Repackaging firm recalling due to potential product cross contamination concerns at the manufacturer.
Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
Sub-potent drug: assay test result below specifications at 9-month timepoint.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
cGMP Deviations
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection.
CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.
cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Lack of assurance of sterility: Suspected microbial growth present on external label packaging.
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Labeling: Label Mix-up
Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.
Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine.
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.
