Yes — there is an active recall. 62 ongoing FDA recalls mention Methyl (501 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methyl. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Reason Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile.
Reason Superpotent Drug: high out of specification assay results for the menthol ingredient.
Reason Lack of assurance of sterility.
Reason Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as…
Reason Labeling: Label Error on Declared Strength: syringes of Neostigmine Methylsulfate 1 mg per mL, 5 mg per 5 mL may be incorrectly labeled as…
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason Lack of Processing Controls: products produced in a manner that calls into question the sterility of the drug product intended to be sterile.
Reason Lack of sterility assurance.
Reason Lack of sterility assurance.
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns…
Reason Failed Dissolution Specification: Low dissolution outside of specifications
Reason Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction…
Reason Defective Delivery System: Out of specification for adhesive transfer.
Reason Presence of Particulate matter. Recall due to presence of unknown particulate matter.
Reason Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method of sterilization.
Reason Failed Impurities/Degradation Specifications
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Reason Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Reason Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
Reason Non-Sterility
Reason Lack of sterility assurance.
Reason Subpotent Drug
Reason Subpotent Drug
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.