Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Is Epinephrine recalled?

Yes — there is an active recall. 19 ongoing FDA recalls mention Epinephrine (118 total). Check the affected lots below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Epinephrine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.

Epinephrine recalls on record

none so far in 2026; 118 on record, newest first
Class II · Moderate risk

Epinephrine/Water

Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

Terminated Sterility / contamination Oregon Compounding Centers, Inc. dba Creative Compounds D-0188-2015
Class II · Moderate risk

Epinephrine Pf Sf*

Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same environment and under the same practices as another product found to be non-sterile and therefore sterility cannot be assured.

Terminated Sterility / contamination Specialty Medicine Compounding Pharmacy D-419-2014
Class II · Moderate risk

Epinephrine 1:1

Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.

Terminated Sterility / contamination JCB Labs LLC D-1047-2013
Class II · Moderate risk

Lidocaine Hydrochloride 2% and Epinephrine 1:100

Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.

Terminated Wrong potency / content Novocol Pharmaceutical of Canada D-923-2013
Class II · Moderate risk

INK-EEZE Tattoo Black Label Numbing Spray

Marketed without an approved NDA/ANDA: INK-EEZE Tattoo Numbing Spray contains 5% Lidocaine and is being marketed without an approved NDA/ANDA. Lidocaine 5% is an ingredient in many FDA approved products, making Ink-Eeze an unapproved new drug.

Terminated Unapproved drug Indelicare LLC D-622-2013
Class II · Moderate risk

Epinephrine **

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1514-2012
Class II · Moderate risk

Bupivacaine HCL & Epinephrine

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1470-2012
Class II · Moderate risk

Atropine Sulfate 0.4mg/Ml Injectable 12 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012 because FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1458-2012
Class II · Moderate risk

Mitomycin/Lidocaine/Epinephrine 0.04%/0.02%/0.1% Injectable 5 Ml

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1583-2012
Class II · Moderate risk

Mepivacaine Hcl/Epinephrine. 2%/1:100

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1570-2012
Class II · Moderate risk

Lidocaine/Epinephrine/Bupivacaine

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1561-2012
Class II · Moderate risk

Lidocaine Hcl/Epinephrine in Bss - P.F.

Lack of Assurance of Sterility: Franck's Lab Inc. initiated a recall of all Sterile Human Drugs distributed between 11/21/2011 and 05/21/2012. FDA environmental sampling revealed the presence of microorganisms and fungal growth in the clean room where sterile products were prepared.

Terminated Sterility / contamination Franck's Lab Inc., d.b.a. Franck's Compounding Lab D-1560-2012