Yes — there is an active recall. 5 ongoing FDA recalls mention Medroxyprogesterone (33 total). Check the affected lots below.
Most common reason: Sterility / contamination (16 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Medroxyprogesterone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Severe thunderstorms caused transit delays of certain cold chain products that were shipped on 02-Apr-2025 and delivered after the 48-hours specified delivery time, on 07-Apr-2025 and 08-Apr-2025. The affected products may not have been stored at the recommended labeled storage conditions which may have impacted the safety, quality, identity, potency and purity of the product.
CGMP Deviations
Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the products purported to be sterile.
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
Lack of assurance of sterility
cGMP deviations: Temperature abuse
cGMP deviations: Temperature abuse
Lack of Assurance of Sterility
Lack of assurance of sterility
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of sterility assurance.
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Lack of Assurance of Sterility
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; all sterile human compounded drugs within expiry
Labeling:Label Mixup; medroxyPROGESTERone ACETATE, Tablet, 10 mg may be potentially mislabeled as hydrALAZINE HCl, Tablet, 100 mg, NDC 23155000401, Pedigree: AD46312_13, EXP: 5/16/2014.
Failed Stability Specifications: Out of specification results for particle size were obtained at the 60 month test point.
Failed Dissolution Specifications: Pfizer Inc. (Pfizer) is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the specification for conjugated estrogens dissolution.
Failed Dissolution Specifications: Pfizer Inc. is recalling PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) because certain lots for this product may not meet the dissolution specification for conjugated estrogens.
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
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