Firmagon Injection Recalled Due to Manufacturing Temperature Abuse
McKesson Medical-Surgical is recalling 25 kits of Firmagon (degarelix for injection) 80 mg nationwide due to temperature abuse during manufacturing. No illnesses have been reported.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for cGMP manufacturing deviation involving temperature abuse. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, placing this at High severity per the rubric.
Plain-English summary
McKesson Medical-Surgical Inc. is recalling Firmagon (degarelix for injection) 80 mg maintenance dose kits from distribution. The recalled product is manufactured by Ferring Pharmaceuticals Inc. with NDC 55566-8303-01. A total of 25 kits have been distributed nationwide in the USA.
The recall was initiated due to a cGMP (current Good Manufacturing Practice) deviation. Specifically, the product was exposed to temperature abuse, which could potentially affect the quality and integrity of the medication.
The affected product was distributed nationwide. Patients and healthcare providers who may have used this product should not use remaining supplies and should consult with their healthcare provider regarding alternative treatment options.
The recalling firm is unable to identify specific lot numbers per customer. Each notification letter includes the distribution date and the dates when impacted product may have been shipped to the customer.
The recalled product
- Product
- Firmagon (degarelix for injection) 80 mg, Maintenance Dose (28 days), packaged in a kit, Rx only, MFG: Ferring Pharmaceuticals Inc., NDC 55566-8303-01
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Category
- Drug
- Hazard
- Affected units
- 25
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 130 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 130 products in this recall →Related recalls
Same manufacturer · Mckesson Medical-Surgical Inc. Corporate Office
See all →- ModerateStrep A test kits recalled after shipment to unlicensed purchasing customers
FDA (Devices) · 2025-08-27
- ModerateProlia prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateEvenity prefilled syringes recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateBenlysta vials recalled after potential temperature excursions during transit delays
FDA (Drugs) · 2025-07-30
- ModerateAbbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue
FDA (Devices) · 2025-06-04
Same hazard · temperature abuse
See all →- SevereKayem Foods Recalls Ready-to-Eat Meat and Poultry Due to Temperature Abuse
USDA FSIS · 2026-10-17
- ModerateZoladex Goserelin Implant Recalled Due to Temperature Abuse
FDA (Drugs) · 2026-10-07
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
Similar recalls
- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateMcKesson Recalls Hydralazine Hydrochloride Injection Due to Temperature Abuse
FDA (Drugs) · 2017-04-19
- ModerateCardinal Health Recalls Auryxia Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- HighMedical device recall for temperature exposure during storage
FDA (Devices) · 2022-08-31
- SevereCardinal Health Recalls Levofloxacin Injection Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- HighInjectable drug recalled for temperature excursion during storage
FDA (Drugs) · 2024-12-18