Testosterone pellets recalled due to incorrect lot number on label
Qualgen is recalling Testosterone 200 mg pellets nationwide due to a printing error that resulted in incorrect lot numbers on the vial labels. The affected product is lot 1043 with expiration date 2/10/2026.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall involving a minor labeling error with no reported illnesses or injuries. The incorrect lot numbers represent a documentation issue rather than a safety-critical product defect.
Plain-English summary
Qualgen, LLC is recalling Testosterone 200 mg pellets packaged in 1mL amber vials (NDC 69761-202-01). The recall affects 2,832 vials distributed nationwide within the United States.
A printing error resulted in incorrect lot numbers printed on the product labels. The affected lot is 1043, with an expiration date of 2/10/2026.
No illnesses or injuries have been reported in connection with this labeling error. Patients who have received this product should consult their healthcare provider or pharmacist regarding the labeling issue. The product should be returned to the pharmacy or dispensing healthcare provider.
The recalled product
- Product
- Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 14844 Bristol Park Blvd Edmond OK 73013, NDC 69761-202-01
- Manufacturer
- Qualgen, LLC
- Category
- Drug
- Hazard
- mis-labeling
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 (2)
- Lot number: 1043
- Exp. Date 2/10/2026
Distribution
Distributed nationwide across the United States.
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