FDA Drug recall D-1012-2022

EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma,…

FDA Drug
Class II
terminated
Published 2022-06-15

On 2022-06-15 the FDA classified a Class II recall of EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma,… by Mckesson Medical Surgical Corporate Office, citing cGMP deviations: Temperature abuse.

Read the official FDA Drug notice

Agency	FDA Drug
Recall number	D-1012-2022
Classification	Class II
Status	terminated
Initiated	2022-04-13
Published	2022-06-15
Last updated	2026-09-13 11:52 UTC
Company	Mckesson Medical Surgical Corporate Office
Distribution	US

Product

EPI-Pen Jr, 2-PAK, (epinephrine injection, USP) Single-Dose Auto-Injectors 0.15 mg, packaged in 2 count carton, Rx only, MFG: Mylan Pharma, NDC 49502-501-02

Reason

cGMP deviations: Temperature abuse

Identifiers

ndc	49502-500-01
ndc	49502-500-02
ndc	49502-500-92
ndc	49502-501-01
ndc	49502-501-02
ndc	49502-501-92
code_info	McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee fo… McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1012-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.