Source: FDA Drug Enforcement (openFDA API)
50 recalls— updated every few hours from the FDA's drug enforcement database.
Medication recalls are issued when a prescription or over-the-counter drug is found to be defective, contaminated, or otherwise unsafe. The FDA's Center for Drug Evaluation and Research (CDER) oversees drug recalls in the United States and maintains the enforcement action database that powers this page.
Common causes of drug recalls include microbial or chemical contamination during manufacturing, incorrect potency (meaning a dose contains more or less of the active ingredient than labeled), labeling errors that could lead to medication errors, the presence of foreign particles or sub-potent ingredients, and products that fail sterility testing. In some cases, recalls occur because a facility failed to meet Good Manufacturing Practice (GMP) standards, even if no specific product defect has been identified yet.
Drug recalls are classified the same way as food recalls. A Class I recall means there is a reasonable probability that using the product will cause or lead to serious adverse health consequences or death — for example, a blood pressure medication with no active ingredient, or an injectable drug contaminated with bacteria. A Class II recall covers products that may cause temporary, reversible health effects. A Class III recall involves products that are unlikely to cause harm but violate FDA regulations.
If you take a recalled medication, do not stop taking a prescription without speaking to your doctor or pharmacist first — abruptly discontinuing some medications can be dangerous. Bring the recalled product to your pharmacy; they can check lot numbers and arrange a replacement. Never flush medication down the toilet unless the recall notice specifically instructs you to. Use the FDA's drug take-back program or an approved disposal method.
CareFusion 213, LLC
Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the packaging of the applicator
Chiesi USA, Inc.
Lack of Assurance of Sterility
Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Cipla USA, Inc.
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Lannett Company Inc.
Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER capsules.
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Bell Pharmaceuticals, Inc
SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%).
Reliance Life Sciences Private Limited
Lack of Sterility Assurance
Reliance Life Sciences Private Limited
Lack of Sterility Assurance
Reliance Life Sciences Private Limited
Lack of Sterility Assurance
Reliance Life Sciences Private Limited
Lack of Sterility Assurance
QuVa Pharma, Inc.
Failed Impurities/Degradation Specifications
Lupin Pharmaceuticals Inc.
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Padagis US LLC
Subpotent Drug: Low out of specification assay results performed during long-term stability testing.
Direct Rx
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
SUN PHARMACEUTICAL INDUSTRIES INC
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
The Harvard Drug Group LLC
Subpotent Drug
Boehringer Ingelheim Pharmaceuticals, Inc.
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Par Health USA, LLC
Crystallization; identified as Buprenorphine free base
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
CareFusion 213, LLC
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
BioMed Laboratories, LLC.
Failed Impurities/Degradation Specifications; Formaldehyde levels exceeded specification.
ACCORD BIOPHARMA INC
Lack of assurance of Sterility:
McKesson
Temperature Abuse: Product was stored incorrectly in a controlled room temperature environment instead of a refrigerated environment.
Asclemed USA Inc.
Lack of Assurance of Sterility
ACCORD HEALTHCARE, INC.
Subpotent Drug
Asclemed USA Inc.
Lack of Assurance of Sterility
ONESOURCE SPECIALTY PHARMA LIMITED
Failed Impurities/Degradation Specifications
Inventia Healthcare Limited
Failed Dissolution Specifications
Annora Pharma Private Limited
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Haleon US Holdings LLC
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Amgen, Inc.
Presence of Foreign Substance.