TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Com...
FDA Drug Recall #D-0412-2025 — Class II — April 28, 2025
Recall Summary
| Recall Number | D-0412-2025 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 28, 2025 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | BSO LLC |
| Location | Lakewood, CO |
| Product Type | Drugs |
| Quantity | 2,762 vials |
Product Description
TESTOSTERONE PELLET 100 mg (with Cholesterol </=4%), 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not for Resale, RX or Office Use Only, Belmar Select Outsources, 12860 W. Cedar Drive #211, Lakewood, CO 80228, NDC: 70168-0101-01
Reason for Recall
Presence of Particulate Matter: Glass particles were found in pellet vials.
Distribution Pattern
Nationwide in the USA
Lot / Code Information
Lot 20250102@6, exp 12/11/2025; Lot 20250130@4, exp 1/22/2026
Other Recalls from BSO LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-0416-2025 | Class II | TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for ... | Apr 28, 2025 |
| D-0415-2025 | Class II | TESTOSTERONE PELLET 200 mg (with Cholesterol </... | Apr 28, 2025 |
| D-0414-2025 | Class II | TESTOSTERONE PELLET 200 mg BLUNT (with Choleste... | Apr 28, 2025 |
| D-0413-2025 | Class II | TESTOSTERONE PELLET 200 mg (with Cholesterol </... | Apr 28, 2025 |
Frequently Asked Questions
Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects 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.