Qualgen Recalls Testosterone Pellets Due to Incorrect Lot and Expiration Dates
Qualgen, LLC is recalling Testosterone 200 mg Pellets because the vials have incorrect or missing lot and expiration dates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences, and the issue is limited to documentation and labeling errors.
Plain-English summary
Qualgen, LLC is recalling Testosterone 200 mg Pellets, 1-count 3ml amber vials, due to labeling errors. The affected product is compounded by Qualgen, LLC, located in Edmond, Oklahoma, and is identified by NDC 69761-120-01.
The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The specific lot number is D001, with an expiration date of 01/02/2018 and a compounded date of 01/02/2019. The product was distributed nationwide in the USA.
Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01
- Manufacturer
- Qualgen, LLC
- Category
- Drug — Compounded Prescription
- 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 (1)
- lot# D001 EXP: 01/02/2018 CPD: 01/02/2019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 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 2 products in this recall →Related recalls
Same manufacturer · Qualgen, LLC
See all →- LowCompounded testosterone pellet vials carry incorrect lot numbers from printing issue
FDA (Drugs) · 2025-07-23
- HighQualgen Recalls Estradiol Pellets Due to Sterility Assurance Concerns
FDA (Drugs) · 2018-11-14
- SevereQualgen Recalls Estradiol Pellets Due to Lack of Sterility Assurance
FDA (Drugs) · 2018-11-14
- HighRecall of Testosterone 12.5mg Pellet due to Sterility Concerns
FDA (Drugs) · 2018-11-14
- HighQualgen Recalls Testosterone Pellets Due to Sterility Concerns
FDA (Drugs) · 2018-11-14
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02