Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fa...

FDA Drug Recall #D-0863-2022 — Class III — March 4, 2022

Recall Summary

Recall Number D-0863-2022
Classification Class III — Low risk
Date Initiated March 4, 2022
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fagron, Inc
Location Saint Paul, MN
Product Type Drugs
Quantity 53 containers

Product Description

Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05

Reason for Recall

Subpotent Drug

Distribution Pattern

Nationwide within the USA

Lot / Code Information

Lot #: 18H02-U02-044978, 18L12-U02-050018, Exp. Date 10/31/2022 18L12-U02-000952, Exp. Date Sep 2023

Other Recalls from Fagron, Inc

Recall # Classification Product Date
D-0154-2024 Class II NYSTATIN 5BU, Activity (as is): 6482 Units/mg, ... Dec 11, 2023
D-0156-2024 Class II NYSTATIN 2 BU, Activity (as is): 6482 Units/mg,... Dec 11, 2023
D-0155-2024 Class II NYSTATIN 500 MU, Activity (as is): 6482 Units/m... Dec 11, 2023
D-0157-2024 Class II NYSTATIN 150 MU, Activity (as is): 6482 Units/m... Dec 11, 2023
D-0862-2022 Class III Nandrolone Decanoate, USP, 100 g per plastic co... Mar 4, 2022

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.