SharpyMounjaro KwikPen India Quality Alert: 6 Batches, What to Do
Six Mounjaro KwikPen batches, one for each strength from 2.5 mg to 15 mg, are listed as "not of standard quality" in India's September 2026 drug alert, based on tests by the Haryana state drug lab. Five entries say the sample failed the assay (strength) test, and the 2.5 mg and 5 mg samples also failed sterility. The flag applies only to those batch numbers, not to all Mounjaro. If your pen's batch matches, do not use it and call your pharmacist and prescriber. While you sort out a safe supply, Sharpy keeps your daily protein and 20-minute workouts on track.
Did Mounjaro KwikPen fail a quality test in India, and is your pen affected? Six Mounjaro KwikPen batches, one for every strength sold in India, are listed as "not of standard quality" in the September 2026 drug alert. The samples were tested by the Haryana state drug lab. Five of the six entries say the sample failed the assay test, which checks how much drug is in the pen. The 2.5 mg and 5 mg samples also failed sterility. The flag covers only these batch numbers, so the first step is to check yours.
The listing was reported on October 25 and 26, 2026, by Medical Dialogues and The South First. Here is what it says, what it does not say, and what to do next.
Mounjaro KwikPen batches flagged in India
These are the six entries in the state lab section of the September 2026 alert.
| Strength (per 0.6 ml) | Batch number | Reported result |
|---|---|---|
| 2.5 mg | D924668 | Failed assay and sterility |
| 5 mg | D928027 | Failed assay, sterility and related substances (impurities) |
| 7.5 mg | D938368 | Failed assay |
| 10 mg | D949702 | Listed, but the wording does not clearly say which test failed |
| 12.5 mg | D894806 | Failed assay |
| 15 mg | D949932 | Failed assay |
All six name Eli Lilly Italy S.p.A. (Sesto Fiorentino, Italy) as the manufacturer and Eli Lilly and Company (India) Pvt. Ltd. (Bhiwandi, Maharashtra) as the importer. The reporting lab is the Government Analyst, Haryana, in Chandigarh.
What the alert leaves out matters too. It gives no test numbers, so we do not know how far below the expected strength any sample was. It gives no manufacturing or expiry dates. And it does not say where the samples were picked up.
What does "not of standard quality" mean?
India's drug regulator, CDSCO, publishes a monthly list of samples that failed testing. A drug is "not of standard quality" (NSQ) when a sample fails one or more quality tests set under the Drugs and Cosmetics Act, 1940. Three tests show up in the Mounjaro entries:
- Assay: does the pen hold the amount of tirzepatide the label says? A failed assay means it did not, at least in that sample.
- Sterility: an injection must be free of germs. A sterility failure is the most serious finding for a shot, because it raises the risk of infection.
- Related substances: a check for impurities, such as broken-down drug.
CDSCO has said in its monthly alerts that an NSQ result is specific to the batch the lab tested and does not point to a problem with other products on the market. So this is not a ban on Mounjaro, and it is not the same as a recall notice.
Is Mounjaro recalled in India?
As of October 26, 2026, we found no recall notice and no public statement from Lilly about these six batches. NSQ is also a different label from "spurious," which is the word Indian regulators use for fakes. None of the Mounjaro entries is marked spurious.
That leaves an open question: were the tested pens genuine Lilly stock that degraded or went wrong, or fakes printed with Lilly's name? The public summaries do not answer it. It is worth knowing that counterfeit Mounjaro was seized in Gurugram, Haryana, in April 2026. Lilly India said at the time that those products were not made by Lilly and did not come from its supply chain. We are not saying the flagged batches are fakes. We are saying the alert alone does not tell us.
What to do if you use Mounjaro KwikPen in India
- Find your batch number. It is printed on the carton and on the pen label, near the expiry date. Compare it letter by letter with the table above.
- If it matches, do not inject from that pen. Keep the pen and box. Call the pharmacy that sold it and your prescriber before your next dose, and ask how to get a replacement from an authorized source.
- If it does not match, the alert does not apply to your pen. Keep using Mounjaro as prescribed.
- Do not change your dose or switch drugs on your own. A missed week or a restart can change which dose is right for you. That is your prescriber's call. Our Mounjaro dosage chart explains how the doses step up on the label.
- Watch for warning signs. If you used a pen and get fever, chills, or a red, hot, swollen or painful injection site, see a doctor.
- Report it. Lilly India lists a toll-free helpline, 1800 123 0021, and the email mailbox_in-gps@lilly.com for suspected counterfeit or quality problems. You can also report a side effect through the Pharmacovigilance Programme of India.
A gap between pens is stressful, and it is easy to drop the habits that protect your muscle when the shot is on hold. Sharpy gives you one protein target, one 20-minute workout and one Shape Score a day, so you have something steady to follow while you get a safe pen.
How to spot a fake Mounjaro pen
Lilly India's advice after the Gurugram seizure:
- Buy only from authorized distributors or licensed pharmacies, with a valid prescription.
- Avoid unlicensed online sellers and "grey market" offers.
- Check for damaged, tampered or resealed packaging.
- Check that the batch number, expiry date and maker details are all printed.
- Look for spelling mistakes, odd logos or labels that differ from your last box.
- Be wary of prices far below the usual price.
In India, Lilly sells tirzepatide under two brand names, Mounjaro and Yurpeak. Our compounded GLP-1 guide explains why products from outside the regulated supply chain carry extra risk.
Mounjaro KwikPen India price
When Lilly launched the KwikPen across India in August 2025, it listed these monthly prices. Each pen holds four once-weekly doses.
| Strength | Launch price per pen (4 weekly doses) |
|---|---|
| 2.5 mg | Rs 14,000 |
| 5 mg | Rs 17,500 |
| 7.5 mg | Rs 22,000 |
| 10 mg | Rs 22,000 |
| 12.5 mg | Rs 27,500 |
| 15 mg | Rs 27,500 |
Pharmacy prices have changed since launch, so check the MRP on your box. A pen offered for much less than this is a red flag.
Does this affect Mounjaro in the US or UK?
No US or UK action has been announced. The alert is from India's monthly testing and names specific batches imported into India. In the US, the recent tirzepatide recall news was about compounded vials from pharmacies, not Lilly's Mounjaro or Zepbound pens. For background on the drug itself, see our Mounjaro guide.
The bottom line
Six Mounjaro KwikPen batches in India failed state lab testing, mostly on drug strength, with two sterility failures. Check your batch number. If it is on the list, set that pen aside and call your pharmacist and prescriber. If it is not, carry on as prescribed and buy only from licensed pharmacies. Whatever happens with your supply, Sharpy helps you hit your protein and keep training so the weight you lose is fat, not muscle.
Sources
- State Drug Alert: CDSCO flags 288 samples including Thyrox, Mounjaro as NSQ in September (Medical Dialogues, Oct 25, 2026)
- Mounjaro KwikPen batches fail quality tests in CDSCO's September drug-quality alert (The South First, Oct 26, 2026)
- CDSCO flags 46 drug batches as NSQ in May 2026, with CDSCO's batch-specific note (Medical Dialogues)
- Lilly supports Haryana State FDA action against counterfeit medicines (IndiaMedToday, Apr 30, 2026)
- Eli Lilly issues alert after fake Mounjaro injections seized in Gurugram (The Tribune, Apr 30, 2026)
- Eli Lilly launches Mounjaro KwikPen in India (BioSpectrum India, Aug 2025)
Questions people ask
Which Mounjaro KwikPen batches failed the quality test in India?
The September 2026 state lab list reported by Medical Dialogues names six batches: D924668 (2.5 mg), D928027 (5 mg), D938368 (7.5 mg), D949702 (10 mg), D894806 (12.5 mg) and D949932 (15 mg). All are 0.6 ml KwikPen strengths, with Eli Lilly Italy named as manufacturer and Eli Lilly India as importer.
Is Mounjaro recalled in India?
Not as a whole. A "not of standard quality" (NSQ) listing is about the batch that was tested. CDSCO has said in its monthly alerts that an NSQ result is specific to that batch and is not a concern about other products on the market. As of October 26, 2026, we found no public recall notice or statement from Lilly about these six batches.
What does "not of standard quality" mean?
It means a sample failed one or more official quality tests under India's Drugs and Cosmetics Act, 1940. For Mounjaro, the failed tests were assay (how much drug is in the pen), sterility (whether it is free of germs) and, for one batch, related substances (impurities). It is a different category from "spurious," which means a fake.
Were these fake Mounjaro pens?
The alert does not say. None of the six entries is labeled spurious, and the public summaries do not say whether the tested pens were genuine Lilly stock. Counterfeit Mounjaro was seized in Gurugram, Haryana, in April 2026, and Lilly said then that those products were not made by Lilly. Until more facts come out, check your batch number and buy only from licensed pharmacies.
How do I find the batch number on my Mounjaro KwikPen?
Look on the outer carton and on the pen label. The batch (sometimes shown as "Lot" or "B. No.") is printed next to the manufacturing and expiry dates. Compare it letter by letter with the six numbers above.
What should I do if my Mounjaro batch is on the list?
Do not inject from that pen. Keep the pen and box, and contact the pharmacy that sold it and your prescriber before your next dose. Ask how to get a replacement from an authorized source. Do not change your dose or switch drugs on your own. If you used a pen and have fever, chills, or a red, hot, swollen or painful injection site, see a doctor.
How can I check if my Mounjaro is genuine in India?
Lilly India advises buying only from authorized distributors or licensed pharmacies with a valid prescription. Warning signs are damaged or resealed packaging, a missing batch number, expiry date or maker details, and spelling or printing errors. Lilly India listed a toll-free helpline, 1800 123 0021, and the email mailbox_in-gps@lilly.com for suspected counterfeits.