Class II · Moderate risk
SEMAGLUTIDE 20mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Rybelsus (semaglutide) (Oral Semaglutide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Rybelsus (semaglutide) Tablets 7 mg Once daily Each tablet contains 7 mg semaglutide 30 tablets 3 blister packs. Each pack contains 10 tablets. Rx only NDC 0169-4307-13 Manufactured by: Novo Nordisk A/S DK-2880 Bagsvaerd, Denmark
Affected NDC
0169-4307-13
Compare with the code on your package — it is the most precise check available.
Drug: Semaglutide
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Rybelsus oral semaglutide NDC 00169-4307 |
SEMAGLUTIDE 7 mg/1 | Tablet Oral |
Novo Nordisk Pharmaceutical Industries, LP | Rx |
- Recalling firm
- Cardinal Health Inc.
- NDC code
- 0169-4307-13
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0536-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Semaglutide recalls
See all
Class II · Moderate risk
SEMAGLUTIDE 10mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 7.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Class II · Moderate risk
SEMAGLUTIDE 2.5mg
Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
Other recalls by Cardinal Health Inc.
All 2021 recalls
Class II · Moderate risk
Enoxaparin Sodium Injection
Correct Labeled Product Mispack: Bags labeled for Enoxaparin Sodium Injection, 80 mg/0.8 mL, contained Enoxaparin Sodium Injection, 30 mg/0.3 mL
Class II · Moderate risk
Recombinate
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
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