The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0235-2019·Announced 2018-11-14

Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

Qualgen, LLC is recalling specific lots of Testosterone 37.5 mg pellets nationwide due to a lack of assurance of sterility.

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: The recall is classified as FDA Class II and involves a risk-of-harm product (sterility issue) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for theoretical or unreported harm risks.

Plain-English summary

Qualgen, LLC is recalling specific lots of Testosterone 37.5 mg pellets, available in 1, 6, 12, and 30-count vials. The recall is being conducted because of a lack of assurance of sterility for the affected products.

The affected lots are C245 (BUD: 11/28/2018), D005 (BUD: 1/5/2019), D027 (BUD: 1/31/2019), D035 (BUD: 2/9/2019), and D058 (BUD: 3/9/2019). These products were distributed nationwide.

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The source text does not provide specific instructions for disposal or return, but users should contact their healthcare provider or the manufacturer for guidance.

The recalled product

Product
Testosterone 37.5 mg pellet, 1 count (NDC 69761-137-01), 6 count (NDC 69761-137-06), 12 count (NDC 69761-137-12) and 30 count (NDC 69761-137-30) vials, Rx Only, Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Injectable Steroids
Hazard

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 (5)

  • Lots: C245 BUD: 11/28/2018
  • D005 BUD: 1/5/2019
  • D027 BUD: 1/31/2019
  • D035 BUD: 2/9/2019
  • D058 BUD: 3/9/2019

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 14 recalled by Qualgen, LLC 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 14 products in this recall →

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