Methylprednisolone Acetate Injectable Suspension
Lack of Assurance of Sterility
Yes — there is an active recall. 5 ongoing FDA recalls mention Methylprednisolone (93 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methylprednisolone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
Lack of Assurance of Sterility
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Lack of sterility assurance.
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Assurance of Sterility: due to concerns with production processes which cannot assure sterility of products intended to be sterile.
Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Lack of Assurance of Sterility
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