The Recall Desk
HighFDA (Drugs)·D-0231-2019·Announced 2018-11-14

Qualgen Recalls Testosterone Pellets Due to Sterility Concerns

Qualgen, LLC is recalling specific lots of Testosterone 100mg pellets nationwide due to a lack of assurance of sterility.

What this means for you

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 failure) where no specific injuries or illnesses are reported in the source text, fitting the criteria for a High severity score.

Plain-English summary

Qualgen, LLC is recalling Testosterone 100mg pellets, available in 1, 6, 12, and 30 count vials, due to a lack of assurance of sterility. The affected products are prescription-only and were distributed nationwide.

The recall includes specific lots with the following codes and best-use dates: C232 (11/3/2018), C239 (11/14/2018), C246 (11/29/2018), C260 (12/19/2018), D004 (1/4/2019), D017 (1/18/2019), D023 (1/26/2019), and D053 (3/6/2019).

Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone 100mg pellet, 1 count (NDC 69761-110-01), 6 count (NDC 69761-110-06), 12 count (NDC 69761-110-12), and 30 count (NDC 69761-110-30) vials, Rx Only Qualgen, LLC, Edmond, OK 73013
Manufacturer
Qualgen, LLC
Category
Drug — Prescription Pellets
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 (8)

  • Lots: C232 BUD: 11/3/2018
  • C239 BUD: 11/14/2018
  • C246 BUD: 11/29/2018
  • C260 BUD: 12/19/2018
  • D004 BUD: 1/4/2019
  • D017 BUD: 1/18/2019
  • D023 BUD: 1/26/2019
  • D053 BUD: 3/6/2019

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 →

Related recalls

Same manufacturer · Qualgen, LLC

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Same hazard · sterility failure

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