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.
10,690 detailed records are currently available in this category.
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Failed Impurities/Degradation Specifications: High out-of-specification results for a related compound obtained during routine stability testing.
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Defective Delivery System: United Therapeutics is voluntarily recalling a small number of Tyvaso Inhalation Systems with Optineb ON-100/7 and TD-100/A medical devices. These devices may…
Presence of Particulate Matter: The bupivacaine HCl injection used to compound this lot of BUPivacaine HCl 0.25% Preservative Free 500 mL in On-Q C-bloc was recalled by the supplier due to…
Presence of Particulate Matter; metal embedded in the glass vial and visible particles floating in the solution
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, Inc. is voluntarily recalling one lot of Fluvastatin Capsules USP, 20 mg due to a customer complaint trend regarding capsule…
Failed Dissolution Specifications: Stability results found the product did not meet the drug dissolution specifications.
Failed Dissolution Specifications: Stability lots cannot support dissolution past the 36 month time point.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Presence of Particulate Matter: Complaints received of discolored solution identified as subvisible particles of iron oxide that are agglomerating.
Incorrect/Undeclared Excipients: Specific drug products were compounded with an incorrect solvent.
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Failed Impurities/Degradation Specifications: this product is being recalled due to an out of specification test result for impurities during stability testing.
Presence of Foreign Tablets/Capsules: Pfizer is recalling 50 mg Pristiq (desvenlafaxine) extended release tablets because a single Pristiq 100 mg tablet was found in a bottle of 50 mg…
Crystallization: Crystal precipitate formation and an increase in the number of complaints associated with a gritty, sand-like feeling in the eye.
Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
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.
