# PeptideScanner FDA enforcement reports

Published: 2026-08-25
Source snapshot: 2026-08-12
Reports: 22

> This PeptideScanner lane is a bounded, dated FDA enforcement-report snapshot connected through an exact openFDA application-number annotation. It is not a medical alert or complete recall-lifecycle tracker, does not establish current product or recall status, does not identify affected lots, and does not provide medical guidance.

## D-0723-2026

- Report date: 2026-07-08
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Lupin Pharmaceuticals Inc\.
- Exact applications: ANDA214457
- Peptide profiles: glucagon
- Source-reported reason: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0723-2026%22&limit=1

## D-0541-2026

- Report date: 2026-05-27
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Lupin Pharmaceuticals Inc\.
- Exact applications: ANDA215421
- Peptide profiles: liraglutide
- Source-reported reason: Presence of particulate matter: a white thread-like structure in the cartridge
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0541-2026%22&limit=1

## D-0519-2026

- Report date: 2026-05-13
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Teva Pharmaceuticals USA, Inc
- Exact applications: ANDA210317
- Peptide profiles: octreotide
- Source-reported reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U\.S Food and Drug Administration \(FDA\) inspection at the contract manufacturer\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0519-2026%22&limit=1

## D-0422-2026

- Report date: 2026-04-15
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Cipla USA, Inc\.
- Exact applications: NDA215395
- Peptide profiles: lanreotide
- Source-reported reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0422-2026%22&limit=1

## D-0423-2026

- Report date: 2026-04-15
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Cipla USA, Inc\.
- Exact applications: ANDA217193
- Peptide profiles: lanreotide
- Source-reported reason: Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0423-2026%22&limit=1

## D-0404-2026

- Report date: 2026-04-01
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Teva Pharmaceuticals USA, Inc
- Exact applications: ANDA210317
- Peptide profiles: octreotide
- Source-reported reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U\.S Food and Drug Administration \(FDA\) inspection at the contract manufacturer\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0404-2026%22&limit=1

## D-0405-2026

- Report date: 2026-04-01
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Teva Pharmaceuticals USA, Inc
- Exact applications: ANDA210317
- Peptide profiles: octreotide
- Source-reported reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U\.S Food and Drug Administration \(FDA\) inspection at the contract manufacturer\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0405-2026%22&limit=1

## D-0406-2026

- Report date: 2026-04-01
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Teva Pharmaceuticals USA, Inc
- Exact applications: ANDA210317
- Peptide profiles: octreotide
- Source-reported reason: Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U\.S Food and Drug Administration \(FDA\) inspection at the contract manufacturer\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0406-2026%22&limit=1

## D-0290-2026

- Report date: 2026-01-21
- FDA classification: Class II
- Source status: Ongoing
- Recalling firm: Cipla USA, Inc\.
- Exact applications: NDA215395
- Peptide profiles: lanreotide
- Source-reported reason: Presence of Particulate Matter\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0290-2026%22&limit=1

## D-1178-2023

- Report date: 2023-10-04
- FDA classification: Class III
- Source status: Terminated
- Recalling firm: Tolmar, Inc\.
- Exact applications: NDA021379
- Peptide profiles: leuprolide
- Source-reported reason: Superpotent Drug - Higher than expected levels of leuprolide acetate in the constituted product\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1178-2023%22&limit=1

## D-0058-2023

- Report date: 2022-11-16
- FDA classification: Class I
- Source status: Terminated
- Recalling firm: Viatris Inc
- Exact applications: ANDA079198
- Peptide profiles: octreotide
- Source-reported reason: Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0058-2023%22&limit=1

## D-0884-2022

- Report date: 2022-05-25
- FDA classification: Class II
- Source status: Completed
- Recalling firm: Cardinal Health Inc\.
- Exact applications: BLA125469
- Peptide profiles: dulaglutide
- Source-reported reason: TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0884-2022%22&limit=1

## D-0773-2021

- Report date: 2021-09-01
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: Eli Lilly &amp; Company
- Exact applications: BLA125469
- Peptide profiles: dulaglutide
- Source-reported reason: Labeling: Label error on declared strength - autoinjector devices labeled as 0\.75 mg / 0\.5 mL actually contain 1\.5 mg / 0\.5 mL of product\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0773-2021%22&limit=1

## D-0417-2021

- Report date: 2021-06-02
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: Cardinal Health Inc\.
- Exact applications: NDA202811
- Peptide profiles: linaclotide
- Source-reported reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0417-2021%22&limit=1

## D-0536-2021

- Report date: 2021-06-02
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: Cardinal Health Inc\.
- Exact applications: NDA213051
- Peptide profiles: semaglutide
- Source-reported reason: CGMP Deviations: Intermittent exposure to temperature excursion during storage\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0536-2021%22&limit=1

## D-0618-2021

- Report date: 2021-04-21
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: Novo Nordisk Inc
- Exact applications: NDA206321
- Peptide profiles: liraglutide
- Source-reported reason: 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\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0618-2021%22&limit=1

## D-0622-2021

- Report date: 2021-04-21
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: Novo Nordisk Inc
- Exact applications: NDA022341
- Peptide profiles: liraglutide
- Source-reported reason: 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\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0622-2021%22&limit=1

## D-1287-2014

- Report date: 2014-05-07
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: AbbVie Inc
- Exact applications: NDA020517
- Peptide profiles: leuprolide
- Source-reported reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1287-2014%22&limit=1

## D-1288-2014

- Report date: 2014-05-07
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: AbbVie Inc
- Exact applications: NDA020517
- Peptide profiles: leuprolide
- Source-reported reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1288-2014%22&limit=1

## D-1289-2014

- Report date: 2014-05-07
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: AbbVie Inc
- Exact applications: NDA020263
- Peptide profiles: leuprolide
- Source-reported reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1289-2014%22&limit=1

## D-1290-2014

- Report date: 2014-05-07
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: AbbVie Inc
- Exact applications: NDA020708
- Peptide profiles: leuprolide
- Source-reported reason: Defective Delivery System: Some Lupron Depot Kits may contain a syringe with a potentially defective LuproLoc needle stick protection device\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1290-2014%22&limit=1

## D-1291-2014

- Report date: 2014-05-07
- FDA classification: Class II
- Source status: Terminated
- Recalling firm: AbbVie Inc
- Exact applications: NDA020517
- Peptide profiles: leuprolide
- Source-reported reason: Defective Delivery System: Some Lupron Depot Kits may containin a syringe with a potentially defective LuproLoc needle stick protection device\.
- Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-1291-2014%22&limit=1

