Compounded testosterone pellet vials carry incorrect lot numbers from printing issue
Compounded Testosterone 200 mg Pellet in 1 mL amber vials is being recalled because a printing issue resulted in incorrect lot numbers on the label. 2,832 vials are affected.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall over a printing error in the lot number on the label, which is a documentation issue with no product defect stated.
Plain-English summary
Testosterone 200 mg Pellet, packaged in 1 mL amber vials, prescription only, a compounded product from Qualgen of Edmond, Oklahoma, NDC 69761-202-01, is being recalled. The action covers 2,832 amber vials.
The stated reason is a labeling issue of incorrect or missing lot and/or expiry date: a printing issue resulted in incorrect lot numbers on the label. The FDA classified the action as Class III, its least serious classification. The source does not describe any defect in the product itself.
The affected lot is 1043, expiring 2/10/2026. Distribution was nationwide within the United States.
Facilities should identify affected stock using the NDC and lot number above and follow the instructions issued by the compounder.
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 — Compounded pellet
- Affected units
- 2,832
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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