EpiPen epinephrine auto-injectors recalled for manufacturing temperature deviation
McKesson Medical-Surgical is recalling EpiPen 0.3 mg epinephrine auto-injectors due to temperature-related manufacturing deviations during the June-September 2021 distribution period.
What this means for you
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 with no reported illnesses or injuries. The hazard—temperature exposure during manufacturing—is a theoretical risk to product quality rather than a documented failure. Per the rubric, theoretical hazards without reported harm score at most 3 (High).
Plain-English summary
McKesson Medical-Surgical Inc. is recalling EpiPen (epinephrine injection, USP) 0.3 mg Single-Dose Auto-Injectors (EPI-PEN 2-PAK), manufactured for Mylan Specialty LP. The recalled products carry NDC 49502-500-02 and were distributed nationwide in the United States.
The recall is due to cGMP (current Good Manufacturing Practice) deviations identified as temperature abuse during manufacturing. The FDA classified this as a Class II recall. Products distributed to customers by McKesson Medical-Surgical between June 1 and September 30, 2021 may have been affected.
Consignees who received products from McKesson during the affected timeframe should use their own records to determine whether they received impacted product and whether any remains in inventory. The recall notification letter sent to each consignee includes the specific distribution dates for that customer. Consignees with questions may contact Sedgwick.
The recalled product
- Product
- EPIPEN (EPINEPHRINE)
- Brand
- EPIPEN
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Affected units
- 5
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 brand · EPIPEN
- HighPrescription EpiPen auto-injectors recalled for temperature-abuse manufacturing defect
FDA (Drugs) · 2022-06-15
- ModerateCardinal Health Recalls EpiPen Auto-Injectors Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
- CriticalEpiPen Jr. Auto-Injectors Recalled for Delivery System Defects
FDA (Drugs) · 2017-05-10
- CriticalEpiPen Auto-Injectors Recalled for Defective Delivery System
FDA (Drugs) · 2017-05-10
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 →- ModerateGemcitabine Injection Recalled Due to Temperature Storage Abuse
FDA (Drugs) · 2026-07-08
- ModerateGarland Fresh peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- ModerateChristopher Ranch peeled garlic recalled over Clostridium botulinum contamination risk
FDA (Food) · 2026-05-13
- SevereCrab Cakes Sold to Food Service Recalled for Botulism Risk
FDA (Food) · 2026-04-15
- CriticalUDENYCA syringes recalled after cartons were stored at room temperature
FDA (Drugs) · 2026-02-18