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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87537

13 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
March 22, 2021
Product types
Drug
Classifications
Class I and Class II
Statuses
Terminated
Recalling firm wording
Novo Nordisk Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

13 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 13

Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk, Inc., Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-3204-90 (Pen), NDC 0169-3204-97 (Kit)

D-0611-2021
Recall number
D-0611-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

KP51207 exp 06/30/2022; KP52618 exp 10/31/2022

Distribution pattern

Nationwide in the USA

drug · product 2 of 13

Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge, 5 cartridges per package, Sample Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3205-91

D-0612-2021
Recall number
D-0612-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

KS6BF84, Exp 06/30/2022

Distribution pattern

Nationwide in the USA

drug · product 3 of 13

Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-3201-90

D-0613-2021
Recall number
D-0613-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

KS6BX63 exp 10/31/2022; KS6AK76 exp 05/31/2022; KS6BR92 exp 09/30/2022

Distribution pattern

Nationwide in the USA

drug · product 4 of 13

Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6438-90 (Pen), NDC 0169-6438-98 (Kit)

D-0614-2021
Recall number
D-0614-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

KP51933 exp 07/31/2022

Distribution pattern

Nationwide in the USA

drug · product 5 of 13

NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insulin Syringe pen, Sample. Not for Resale, Rx Only, Novo Nordisk Inc., Plainsboro, NJ 08536, NDC 0169-6339-90 (Pen), NDC 0169-6339-98 (Kit)

D-0615-2021
Recall number
D-0615-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

KS6BS11, Exp 11/30/2021

Distribution pattern

Nationwide in the USA

drug · product 6 of 13

NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx Only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark NDC 0169-7501-90

D-0616-2021
Recall number
D-0616-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

JZFC826 exp 06/30/2021; KZFM305 exp 08/31/2022

Distribution pattern

Nationwide in the USA

drug · product 7 of 13

OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pen, Sample. Not for Resale, Rx only, Novo Nordisk Inc, Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-4132-90 (Pen), NDC 0169-4132-97 (Kit)

D-0617-2021
Recall number
D-0617-2021
Initiated
March 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

KP50867, exp 10/31/2022, KP53021, exp 04/30/2023, KP52338, exp 02/28/2023, JP54354, exp 08/31/2022, KP50676, exp 10/31/2022, KP51434, exp 11/30/2022, KP51491, exp 11/30/2022, KP51781, exp 01/31/2023, KP52249, exp 01/31/2023, KP52270, exp 01/31/2023, KP52722, exp 01/31/2023, KP52973, exp 01/31/2023, KP53031, exp 01/31/2023, KP53221, exp 12.04.2023, KP53369, exp 01/31/2023

Distribution pattern

Nationwide in the USA

drug · product 8 of 13

Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen, Sample. Not for Resale., Rx only, Novo Nordisk Inc., Plainsboro, NJ 08536, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2800-90 (Pen), NDC 0169-2800-97 (Kit)

D-0618-2021
Recall number
D-0618-2021
Initiated
March 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

K1620A1 (Kit); KZFH714 (Pen) exp 05/31/2022; B2020A (Kit); JZFF482 (Pen) exp 11/30/2021; I2320A (Kit); KZFH714 (Pen) exp 05/31/2022; H1020A (Kit); KZFH714 (Pen) exp 05/31/2022; J0520A(Kit); KZFH714 (Pen) exp 05/31/2022

Distribution pattern

Nationwide in the USA

drug · product 9 of 13

TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Movo Mordisk Inc., Plainsboro, NJ 08536, NDC 0169-2660-90 (Pen), NDC 0169-2660-97 (Kit)

D-0619-2021
Recall number
D-0619-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

JP52771 exp 09/30/2021; JP53136 exp 06/30/2021; KP50575 exp 01/31/2022; KP50976 exp 01/31/2022; KP51813 exp 04/30/2022; KP52035 exp 04/30/2022; KP52117 exp 04/30/2022; KP52440 exp 06/30/2022; KP52461 exp 04/30/2022; KP52616 exp 06/30/2022; JP52361 exp 08/01/2021

Distribution pattern

Nationwide in the USA

drug · product 10 of 13

TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-dose vial, Sample. Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, NDC 0169-2662-90

D-0620-2021
Recall number
D-0620-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

JZFE233 exp 11/30/2021

Distribution pattern

Nationwide in the USA

drug · product 11 of 13

TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Prefilled Pen, Sample, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2550-90 (Pen), 0169-2550-97 (Kit)

D-0621-2021
Recall number
D-0621-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

KP52829 exp 07/31/2022; JP54181 exp 09/30/2021; KP51059 exp 11/30/2021; KP51865 exp 11/30/2021; KP54179 exp 11/30/2022; JP52179 exp 08/16/2021

Distribution pattern

Nationwide in the USA

drug · product 12 of 13

ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pen, Sample Not for Resale, Rx only, Manufactured by: Novo Nordisk A/S, Bagesvaerd, Denmark NDC 0169-4060-90 (Pen), 0169-4060-99 (Kit)

D-0622-2021
Recall number
D-0622-2021
Initiated
March 22, 2021
Classification
Class II
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

I2419A (Kit); JS68K86 (Pen) exp 05/31/2021

Distribution pattern

Nationwide in the USA

drug · product 13 of 13

Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL and 3.6 mg/mL, 3 mL Prefilled Pen, SAMPLE, Rx only, Manufactured by: Novo Nordisk A/S, Bagsvaerd, Denmark, Distributed by: Novo Nordisk Inc, Plainsboro, NJ 08536, NDC 0169-2911-90 (Pen) NDC 0169-2911-97 (Kit)

D-0623-2021
Recall number
D-0623-2021
Initiated
March 22, 2021
Classification
Class I
Status
Terminated
Recalling firm
Novo Nordisk Inc
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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.

Code information

JP54291, exp 06/20/2021

Distribution pattern

Nationwide in the USA