Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded product. Qualgen 1484...
FDA Drug Recall #D-0517-2025 — Class III — June 16, 2025
Recall Summary
| Recall Number | D-0517-2025 |
| Classification | Class III — Low risk |
| Date Initiated | June 16, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Qualgen, LLC |
| Location | Edmond, OK |
| Product Type | Drugs |
| Quantity | 2,832 amber vials |
Product Description
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
Reason for Recall
Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.
Distribution Pattern
Nationwide within the United States.
Lot / Code Information
Lot number: 1043, Exp. Date 2/10/2026
Other Recalls from Qualgen, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0234-2019 | Class II | Testosterone 25 mg pellet, 1 count (NDC: 69761-... | Oct 17, 2018 |
| D-0236-2019 | Class II | Testosterone 50mg pellet, 1 count (NDC 69761-15... | Oct 17, 2018 |
| D-0227-2019 | Class II | Estradiol 15mg pellet, 1 count (NDC 69761-015-0... | Oct 17, 2018 |
| D-0226-2019 | Class II | Estradiol 12.5mg pellet, 1 count (NDC 69761-012... | Oct 17, 2018 |
| D-0231-2019 | Class II | Testosterone 100mg pellet, 1 count (NDC 69761-1... | Oct 17, 2018 |
Frequently Asked Questions
Stop using the medication immediately and contact your pharmacist. A mislabeling recall can range from a minor technical error (wrong font size) to a serious mix-up where one drug is inside another drug's packaging. If you received a medication that looks or acts differently than expected, or if you experienced unexpected effects, tell your doctor immediately. The pharmacist can verify whether your specific lot is affected and provide a replacement. Report any adverse effects experienced to FDA MedWatch at 1-800-FDA-1088.
Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.
Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.
What Should You Do?
Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.