InvaGen Pharmaceuticals, Inc. recalls Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial,
InvaGen Pharmaceuticals recalls testosterone cypionate injections with particulate matter. Affected lots manufactured in India and shipped to US. Stop using immediately if you have the recalled product.
Stop using this now
Presence of Particulate Matter.
Contact the company & request your remedy
What happened, in plain English
InvaGen Pharmaceuticals is recalling testosterone cypionate injections that may contain particulate matter. This could cause serious injury if injected. The recall affects specific lots manufactured between 2019 and 2020. Read more at govinfonow.com/recall/39073-invagen-testosterone-cypionate-injection-recall-particulate-matter-hazard.
Source Summary by GovInfoNow · govinfonow.com/recall/39073-invagen-testosterone-cypionate-injection-recall-particulate-matter-hazard · Updated October 5, 2026 · FDA enforcement record: FDA #D-1125-2019
Cite this page
“InvaGen Testosterone Cypionate Injection Recall: Particulate Matter Hazard.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39073-invagen-testosterone-cypionate-injection-recall-particulate-matter-hazard. Based on FDA recall #D-1125-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1125-2019%22&limit=1).
Why it’s dangerous
Particulate matter in the injection can cause blockages or serious injury when injected into muscle tissue. This is a known risk with medications that contain particles.
Who’s affected
People who have the recalled testosterone cypionate injection vials (10 mL) with specific lot numbers from India. Men using this medication for hormone replacement therapy are most at risk.
How to tell if you have this one
Check the lot numbers on the vial: GH80216 (expires 1/2020), GH80322/GH80323 (expires 2/2020), or GH90072 (expires 12/2020). The product is a 10 mL vial for intramuscular use only.
- Brand
InvaGen Pharmaceuticals- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide in the U.S.A.- NDC
69097-536-37, 69097-537-37, 69097-537-31
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-1123-2019 | Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37.; Lot #: GH80159, GH80160, GH80161 Exp 01/2020; GH80489, GH80490, GH80502, GH80503, GH80504 Exp 03/2020; GH80557, GH80598, GH80601, GH80602 Exp 04/2020; GH80845, GH80846, GH80855, GH80856, GH80857, GH80877 Exp 06/2020; GH80903, GH80908, GH80931 Exp 07/2020; GH81047 Exp 08/2020. | 12234 vials |
| D-1124-2019 | Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31.; Lot #:GH80009, GH80010, GH80011 Exp 12/2019; GH80568, GH80575, GH80579, GH80580, GH80581, GH80582 Exp 4/2020; GH80646, GH80664, GH80665, GH80684, GH80699, GH80700, GH80701, GH80746, GH80761, GH80765, GH80777 Exp 05/2020; GH80801, GH80823, GH80828, GH80878 Exp 06/2020; GH80967, GH80968, GH81033, GH81034 Exp 07/2020; GH81042, GH81154 Exp 08/2020; GH81255, GH81256, GH81288, GH81289, GH81310 Exp 10/2020 and GH81311 Exp 10/2020 | 692538 vials |
| D-1125-2019 | Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.; Lots #: GH80216 Exp 1/2020; GH80322, GH80323 Exp 2/2020; GH90072 Exp 12/2020. | 75968 vials |
What to do — step by step
Stop Using Immediately
Discard the vial if you have the recalled lot numbers listed in the recall notice.
Questions people ask
What is the specific hazard with this product?
The product may contain particulate matter, which can cause serious injury when injected.
Which lot numbers are affected?
Lots GH80216 (expires 1/2020), GH80322 and GH80323 (expires 2/2020), and GH90072 (expires 12/2020).
How can I check if I have the recalled product?
Look for the lot numbers on the vial: GH80216, GH80322, GH80323, or GH90072. The product is a 10 mL vial for intramuscular use only.
Contact InvaGen Pharmaceuticals
We’ve drafted a message you can send InvaGen Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1125-2019 — InvaGen Pharmaceuticals InvaGen Pharmaceuticals Hello, I own a InvaGen Pharmaceuticals that is covered by recall D-1125-2019 from InvaGen Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1125-2019 (March 22, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1125-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.