Semaglutide Recall 2026: Canada Generics, Compounded Vials, Wegovy
There is no recall of all semaglutide, but several specific products have been pulled. In August 2026, Health Canada posted three Type II recalls of generic semaglutide pens: one Apotex lot that can show and give a 2 mg dose, and Dr. Reddy's lots with a wrong pen in the box or an impurity out of specification. In the US, FDA enforcement reports list Class II recalls of compounded semaglutide from Apollo Care, Carolina Infusion and others, plus four lots of brand-name Wegovy pens from late 2025. Check the lot number on your box, talk to your pharmacist or prescriber before you stop, and keep protecting your muscle with Sharpy.
Is semaglutide being recalled? Some semaglutide is, but not all of it. The recalls are lot by lot. In Canada, Health Canada pulled specific lots of generic semaglutide pens from Apotex and Dr. Reddy's in August 2026. In the US, the FDA lists recalls of compounded semaglutide from several pharmacies, and four lots of brand-name Wegovy pens from December 2025. If the lot number on your box is not on a list below, your medicine is not part of these recalls.
The topic is back in the news this week. US outlets reported on October 19 to 21, 2026 that compounded GLP-1 injections were recalled nationwide over sterility concerns. Most of that coverage is about tirzepatide, which we cover in our tirzepatide recall guide. This guide covers semaglutide, the drug in Ozempic, Wegovy and Rybelsus.
Semaglutide recall Health Canada: the generic pens
Canada is the first G7 country with generic semaglutide pens, after Novo Nordisk's Canadian patent lapsed. Dr. Reddy's received Health Canada approval on April 28, 2026, and Apotex also sells a version called Apo-Semaglutide. Within weeks, three Type II recalls were posted.
| Recall | Company | Product (DIN) | Lots | Problem | Posted |
|---|---|---|---|---|---|
| RA-82477 | Dr. Reddy's | Semaglutide Injection, labeled 2 mg/pen (02567806) | 7000544C | A 4 mg pen inside a box labeled 2 mg | August 12, 2026 |
| RA-82537 | Dr. Reddy's | Semaglutide Injection (02567806 and 02567814) | 7000544, 7000545, 7000546; 7000542, 7000543, 7000624, 7000628, 7000629 | An impurity out of specification | August 27, 2026 |
| RA-82536 | Apotex | Apo-Semaglutide 2 mg/pen (02568020) | 7000599A | The pen may show and give a 2 mg dose when 0.25 mg or 0.5 mg is expected | August 27, 2026 |
The Apotex and wrong-pen recalls are about getting more drug than you meant to. The impurity recall is about quality. Health Canada did not name the impurity or describe a health risk.
What Type II means in Canada
Health Canada uses Type II when using the product "may cause temporary adverse health consequences," or when serious harm is unlikely. Type I is the most serious level. All three semaglutide recalls are Type II, and they were made at the retail level, so pharmacies were told to pull the stock.
How to check a Canadian pen
- Find the DIN and lot number on the carton or pen label.
- Compare them with the table above.
- If they match, do not use the pen. Call your pharmacist, and ask your prescriber what to do before your next dose.
- If you took a dose from an affected pen and feel unwell, for example with strong nausea, vomiting or signs of low blood sugar, get medical care.
Health Canada's own advice is to talk to your healthcare provider before you stop the product. That matters most for people using semaglutide for type 2 diabetes.
Semaglutide recalls in the US: compounded vials
Compounded semaglutide is made by pharmacies, not by Novo Nordisk, and it is not FDA-approved. FDA enforcement reports list these recent semaglutide recalls. All are Class II.
| Pharmacy | Product | Reason | Started | Reach |
|---|---|---|---|---|
| Carolina Infusion, Ridgeland, SC | Semaglutide and semaglutide with B12 in patient-specific syringes | Lack of assurance of sterility | September 10, 2026 | Nationwide |
| Apollo Care, Columbia, MO | Semaglutide and semaglutide with glycine vials, 11 listings, about 162,000 vials | Particles identified as nylon and silk-type protein material | July 29, 2026 | Nationwide |
| Payless Compounders, Beaverton, OR | Semaglutide, glycine and B12 vials (91) | Lack of assurance of sterility | March 6, 2026 | Oregon |
| New Life Pharma, Northvale, NJ | Semaglutide multi-dose vials (822) | Lack of assurance of sterility | February 26, 2026 | Ohio |
| Harbin Jixianglong Biotech, China | Semaglutide powder for compounding | Process and endotoxin tests not validated | February 13, 2026 | Nationwide |
| ProRx, Exton, PA | Semaglutide multi-dose vials, about 36,000 | Lack of assurance of sterility | October 15, 2025 | Texas and Utah |
Two things stand out. The Apollo Care recall is the largest by far. And the Harbin Jixianglong recall is for the raw powder that pharmacies use to make vials, so the problem started before the pharmacy step.
The FDA says it does not review compounded drugs for safety, quality or effectiveness before they are sold. Our compounded GLP-1 guide explains how compounding works and why the rules tightened after the shortage ended.
Was Wegovy or Ozempic recalled?
Wegovy: yes, four lots. On December 19, 2025, Novo Nordisk started a voluntary Class II recall after hair was found in a prefilled pen.
| Wegovy strength | Lots | Expiration |
|---|---|---|
| 0.5 mg/0.5 mL pens | RZFHD52, RZFHW93 | October 31, 2026 |
| 1 mg/0.5 mL pens | RZFYK06, RZFYA53 | March 31, 2027 |
Ozempic: no recall in current FDA enforcement reports. The FDA has warned about counterfeit Ozempic 1 mg pens in the US supply chain. One fake used the real lot PAR0362 with serial numbers starting 51746517. The FDA later named another lot, PAR1229. Fakes are not a recall of the real drug, but the advice is the same: do not use them, and buy only from a licensed pharmacy.
What to do if your semaglutide is on a recall list
- Do not inject it. Set it aside and keep the box, so the pharmacy can see the lot.
- Call the pharmacy that filled it. Ask for a replacement from an unaffected lot.
- Call your prescriber before your next dose. If you miss doses or switch products, they decide how to restart. Do not guess a dose yourself.
- Watch for symptoms. Fever, redness or swelling at the injection site can point to infection. Strong nausea or vomiting after a bigger-than-expected dose needs a call to your doctor.
- Report problems. In Canada, use Health Canada's side effect reporting. In the US, use the FDA's MedWatch program.
A break or change in treatment can bring hunger back fast. That is when muscle is easiest to lose and hardest to rebuild. Sharpy gives you one protein target, one 20-minute workout and a daily Shape Score, so your routine keeps going even when your medicine is on hold. Our 7-day GLP-1 meal plan can help you hit protein while your appetite shifts.
Is semaglutide safe after all these recalls?
Recalls sound scary, but they show that checks are working. Approved semaglutide (Ozempic, Wegovy, Rybelsus and the Canadian generics) is made under drug quality rules and tested lot by lot. When a lot fails, it is pulled. The risk is higher with compounded and research-grade semaglutide, which skip FDA approval. The FDA has said it received 990 adverse event reports for compounded semaglutide as of May 31, 2026, and it notes that reports alone do not prove the drug caused the problem.
If you want the brand-name drug at a lower price instead of a compounded one, see our Ozempic weight loss guide and talk to your prescriber about options.
The bottom line
The 2026 semaglutide recalls are about specific lots: Apotex and Dr. Reddy's generic pens in Canada, compounded vials from US pharmacies, and four older Wegovy lots. Brand-name Ozempic is not recalled. Check your lot, do not inject a recalled product and call your pharmacist and prescriber. Then keep your protein and strength habits steady with Sharpy, so the weight you lose stays fat, not muscle.
This guide is general information, not medical advice. Your prescriber decides what is right for you.
Sources
- Apo-Semaglutide Injection: Incorrect dose display (RA-82536), Health Canada, August 27, 2026
- Semaglutide Injection: Incorrect pen in package (RA-82477), Health Canada, August 12, 2026
- Semaglutide Injection: Out-of-specification impurity (RA-82537), Health Canada, August 27, 2026
- What is a recall? Recall types, Health Canada
- Drug recall enforcement reports for semaglutide, openFDA (checked October 21, 2026)
- FDA Enforcement Reports
- FDA warns consumers not to use counterfeit Ozempic found in U.S. drug supply chain, FDA (updated December 5, 2025)
- FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss, FDA
- Dr. Reddy's becomes first to secure Health Canada nod for generic semaglutide injection, Indian Pharma Post
- MedWatch: FDA Safety Information and Adverse Event Reporting Program
Questions people ask
Is semaglutide being recalled?
Not as a whole. Specific lots and products are. In Canada, Health Canada recalled one lot of Apo-Semaglutide (Apotex) and several lots of Dr. Reddy's semaglutide injection in August 2026. In the US, the FDA lists recalls of compounded semaglutide from several pharmacies and four lots of Wegovy pens recalled by Novo Nordisk in December 2025. If your lot is not on a list, it is not part of these recalls.
What is the Apotex semaglutide recall?
Health Canada recall RA-82536, published August 27, 2026, covers Apo-Semaglutide 2 mg/pen (DIN 02568020), lot 7000599A. The pen may show a 2 mg dose in the dose window and give 2 mg when the person expects 0.25 mg or 0.5 mg. It is a Type II recall.
What is the Dr. Reddy's semaglutide recall?
There are two. RA-82477 (August 12, 2026) covers lot 7000544C of DIN 02567806, where a 4 mg pen was packed in a box labeled 2 mg. RA-82537 (August 27, 2026) covers lots 7000544, 7000545 and 7000546 of DIN 02567806 and lots 7000542, 7000543, 7000624, 7000628 and 7000629 of DIN 02567814, because an impurity was out of specification. Both are Type II.
Is Ozempic recalled?
No current FDA enforcement report lists a recall of brand-name Ozempic. Novo Nordisk did recall four lots of Wegovy pens in December 2025 after hair was found in a prefilled pen. Separately, the FDA has warned about counterfeit Ozempic 1 mg pens, which are fakes, not a recall of the real product.
What should I do if my semaglutide is recalled?
Compare the lot number on your box or label with the recall list. If it matches, do not inject it, and call your pharmacist and prescriber before your next dose to get a replacement and a plan. Do not change your dose on your own. Report side effects to Health Canada or to the FDA's MedWatch program.
Is semaglutide safe?
FDA- and Health Canada-approved semaglutide products have been studied in large trials and are made under strict quality rules. Recalls happen when a lot fails those rules, which is the system working. Compounded semaglutide is not FDA-approved, and the FDA says it does not review compounded drugs for safety, quality or effectiveness before they are sold.