Browse Drug Recalls
18 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 18 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 0.5 mg/0.5 mL, 4 Single-Dose Prefilled Pens, ... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Dec 19, 2025 | Wegovy (semaglutide) Injection, 1 mg/0.5 mL, 4 Single-Dose Prefilled Pens, Ma... | Presence of Particulate Matter: Hair was found in a prefilled syringe | Class II | Novo Nordisk Inc. |
| Apr 9, 2025 | Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens ... | Temperature abuse: Wegovy product was potentially exposed to temperatures outside of the products... | Class II | Cardinal Health Inc. |
| Mar 22, 2021 | TRESIBA FlexTouch (insulin degludec injection) 200 units/mL (U-200), 3 mL Pre... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | NovoLog (Insulin aspart) Injection, 100 units/mL (U-100), One 10 mL multi-dos... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | TRESIBA FlexTouch (insulin degludec injection) 100 units/mL (U-100), 3 mL Pre... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Fiasp FlexTouch (insulin aspart injection) 100 units/mL (U-100), 3 mL Prefill... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Fiasp (insulin aspart injection), 100 units/mL (U-100), One 10 mL multi-dose ... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Levemir FlexTouch (insulin detemir) injection, 100 units/mL (U-100), 3 mL Pre... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Xultophy 100/3.6 (insulin degludec and liraglutide injection), 100 units/mL a... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Fiasp PenFill (insulin aspart injection) 100 units/mL (U-100), 3 mL cartridge... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | TRESIBA (insulin degludec injection) 100 units/mL (U-100), One 10 mL multi-do... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | ViCTOZA (liraglutide) injection, 18 mg/3 mL (6 mg/mL), contains: 1 Victoza Pe... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class II | Novo Nordisk Inc |
| Mar 22, 2021 | OZEMPIC (semaglutide) injection, 2 mg/1.5 mL (1.34 mg/mL) Prefilled pen, 1 pe... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class II | Novo Nordisk Inc |
| Mar 22, 2021 | NovoLog FlexPen (insulin aspart) Injection, 100 units/mL, 3 mL Prefilled Insu... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class I | Novo Nordisk Inc |
| Mar 22, 2021 | Saxenda (liraglutide) Injection, 18 mg/3 mL (6 mg/mL), 1 x 3 mL Prefilled Pen... | Temperature Abuse: product samples were stored at temperatures below 32* F which is not in accord... | Class II | Novo Nordisk Inc |
| Sep 8, 2016 | GlucaGen HypoKit (glucagon [rDNA origin] for injection), 1 mg per vial, Singl... | Defective delivery system: detached needles on the syringe in the kit. | Class I | Novo Nordisk Inc |
| Apr 27, 2016 | Norditropin FlexPro Somatropin (rDNA origin) injection, 30 mg/3 mL Prefilled ... | Defective Delivery System; may have a low frequency assembly fault which may result in pens block... | Class II | Novo Nordisk Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.