TESTOSTERONE PELLET 200 mg BLUNT, 1 Pellet for Subcutaneous Use, This is a Compounded Drug, Not f...

FDA Drug Recall #D-0416-2025 — Class II — April 28, 2025

Recall Summary

Recall Number D-0416-2025
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 1,964 vials

Product Description

TESTOSTERONE PELLET 200 mg BLUNT, 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: 70168-0121-01

Reason for Recall

Presence of Particulate Matter: Glass particles were found in pellet vials.

Distribution Pattern

Nationwide in the USA

Lot / Code Information

Lot 20250129@1, exp 1/17/2026; Lot 20250218@4, exp 1/25/2026

Other Recalls from BSO LLC

Recall # Classification Product Date
D-0412-2025 Class II TESTOSTERONE PELLET 100 mg (with Cholesterol </... 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.