Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility
Is Hydroxyprogesterone recalled?
Not under an active recall.
Hydroxyprogesterone was recalled 33 times in the past — all now closed. Most recent: Mar 26, 2020.
Most common reason: Sterility / contamination (29 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroxyprogesterone. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydroxyprogesterone recalls on record
none so far in 2026; 33 on record, newest first
Class II · Moderate risk
Hydroxyprogesterone Caproate Injection
Lack of Assurance of Sterility
Class II · Moderate risk
C-Hydroxyprogesterone Capro 250mg/Ml Injection
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection
Lack of Assurance of Sterility.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250 Mg/Ml Oil* Injectable
Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
Class II · Moderate risk
Hydroxyprogesterone liquid
Lack of sterility assurance.
Class II · Moderate risk
Hydroxyprogesterone Caproate USP for prescription compounding
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class II · Moderate risk
hydroxyprogesterone w/ pres
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
hydroxyprogesterone in sesame 250 mg/mL
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
17-Hydroxyprogesterone 250mg/mL Injection
Lack of Assurance of Sterility
Class II · Moderate risk
All Products Intended to be Sterile
Lack of Assurance of Sterility
Class II · Moderate risk
17-Alpha Hydroxyprogesterone 250 mg/mL in Sesame Oil Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
17-Alpha Hydroxyprogesterone 250 mg/mL in Castor Oil Injection
Lack of Assurance of Sterility: A recall of all compounded sterile preparations within expiry is being initiated due to observations associated with poor sterile production practices resulting in a lack of sterility assurance for their finished drugs.
Class II · Moderate risk
Hydroxyprogesterone Caproate Oil
Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk
SIH-Hydroxyprogesterone Caproate 250
Lack of Assurance of Sterility: Due to lack of documentation of proper environmental monitoring during the time in which the medication was produced.
Class II · Moderate risk
17-Hydroxyprogesterone 250 mg/mL Injectable
Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility
Class II · Moderate risk
17-HP Hydroxyprogesterone 250mg/1ml Injection
Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk
Hydroxyprogesterone Caproate active pharmaceutical ingredient…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250 Mg/Ml
Crystallization: Formation of crystals observed in product.
Class II · Moderate risk
Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil
Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping
Class II · Moderate risk
Hydroxyprogesterone Caproate
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
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