Agency classClass IIOur severity:High FDA (Drugs)·D-0206-2023·Announced 2023-02-01

Pharmacy Innovations recalls injectable estradiol and testosterone products nationwide for sterility assurance

Pharmacy Innovations recalls multiple injectable estradiol and testosterone products due to insanitary facility conditions that compromise sterility assurance. The products were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall with a real hazard to patient safety (lack of sterility assurance due to facility conditions), but no reported illnesses or injuries. This represents a risk-of-harm situation where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Pharmacy Innovations is recalling multiple injectable estradiol and testosterone products distributed nationwide due to insanitary conditions identified during an FDA inspection of the manufacturing facility.

The recalled formulations include estradiol cypionate and testosterone cypionate injectables in various strengths and vial sizes. The insanitary conditions create a lack of assurance of product sterility, which is critical for injectable medications intended for human use.

Patients currently using these products should contact their healthcare provider or pharmacist immediately. Providers may need to assess the need for alternative therapy or replacement products. Specific lot information is available through the FDA and the manufacturer.

The recalled product

Product: ESTRADIOL CYP/TEST CYP- SS OIL- 2MG/50MG/ML (1.5ML VIAL) INJECTABLE; ESTRADIOL CYP/TEST CYP -SS OIL- 2MG/25MG/ML (1ML VIAL) INJECTABLE; ESTRADIOL CYP-CS OIL- 5MG/ML (1.25ML VIAL) INJECTABLE; ESTRADIOL CYP-GS OIL- 5MG/ML (1ML VIAL) INJECTABLE ESTRADIOL CYP-SS OIL- 5MG/ML (1.5ML…
Manufacturer: Pharmacy Innovations
Category: Drug — Injectable
Hazard: lack-of-sterility
contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

t20221109@7 t20221027@6 t20221010@8 t20221116@36 t20221111@45 t20221026@41

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 59 recalled by Pharmacy Innovations under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 59 products in this recall →

Same manufacturer · Pharmacy Innovations

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Same hazard · lack of sterility