Is Methyl recalled?
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.
Class II · Moderate risk Terminated Nov 16, 2017
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class III · Low risk Terminated Oct 17, 2017
Reason Failed Dissolution Specifications: Low out of specification results for dissolution.
Class III · Low risk Terminated Sep 25, 2017
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk Terminated Sep 25, 2017
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class II · Moderate risk Terminated Sep 25, 2017
Reason Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Class II · Moderate risk Terminated Sep 5, 2017
Reason Superpotent Drug: Subpotent Drug. FDA analysis found this product to be Out of Specification for assay which could result in either Subpotent and/or…
Class II · Moderate risk Terminated Aug 30, 2017
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated Aug 30, 2017
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated Aug 30, 2017
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated Aug 30, 2017
Reason Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Class II · Moderate risk Terminated Aug 15, 2017
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated Aug 15, 2017
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated Aug 10, 2017
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product…
Class II · Moderate risk Terminated Aug 10, 2017
Reason Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds current stability data.
Class III · Low risk Terminated Aug 4, 2017
Reason Failed Dissolution Specifications
Class III · Low risk Terminated Aug 4, 2017
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated Jul 14, 2017
Reason Lack of Sterility Assurance.
Class I · High risk Terminated Jun 6, 2017
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class I · High risk Terminated Jun 6, 2017
Reason Marketed without an approved NDA/ANDA: product label states it contains anabolic steroids.
Class II · Moderate risk Terminated Jun 1, 2017
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated Apr 18, 2017
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated Apr 18, 2017
Reason Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Class II · Moderate risk Terminated Apr 17, 2017
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk Terminated Apr 17, 2017
Reason CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
Class II · Moderate risk Terminated Apr 6, 2017
Reason Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.