Class II · Moderate risk
Myxredlin
CGMP Deviations
Is Insulin recalled?
Yes — there is an active recall. 3 ongoing FDA recalls mention Insulin (24 total). Check the affected lots below.
Most common reason: Temperature excursion (12 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Insulin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Insulin recalls in 2026
1 initiated in 2026, 24 in total — newest first
Class II · Moderate risk
Sterile Diluent
CGMP Deviations
Class II · Moderate risk
Admelog
Lack of Assurance of Sterility: Malformed crimped collar seal
Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk
Insulin Glargine
Labeling: Missing label on the vial
Class I · High risk
Humalog KwikPen
TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Class I · High risk
Semglee (insulin glargine)
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Class I · High risk
Xultophy 100/3.6
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
TRESIBA FlexTouch
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
TRESIBA (insulin degludec injection)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
TRESIBA FlexTouch
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
NovoLog (Insulin aspart)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
NovoLog FlexPen
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
Levemir FlexTouch
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
Fiasp (insulin aspart injection)
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
Fiasp PenFill
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class I · High risk
Fiasp FlexTouch
Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accordance with storage requirements that could cause a lack of efficacy and damage to the cartridge and pen-injectors.
Class II · Moderate risk
Admelog Solostar
Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.
Class II · Moderate risk
Insulin
Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.
Class II · Moderate risk
Insulin Regular
Lack of Assurance of Sterility
Class II · Moderate risk
PZI 40 Insulin
Lack of Assurance of Sterility
Class II · Moderate risk
Bovine Insulin active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Humulin-R Insulin
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.
Class II · Moderate risk
Insulin
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.
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