CLASS II Drug recall · Reported 24 Apr 2019 · FDA Enforcement Report

Testosterone Cypionate Injection, USP, 2000 mg/ (200 mg/mL) recalled

InvaGen Pharmaceuticals is recalling Testosterone Cypionate Injection, USP, 2000 mg/ (200 mg/mL), For intramuscular use only, distributed nationwide in the US. The recall was initiated on 22 Mar 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: 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.

NDC69097-536, 69097-537

UPC0369097536374, 0369097537371, 0369097537319

Quantity recalled12234 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-1123-2019
FDA event ID: 82463
Recalling firm: InvaGen Pharmaceuticals, Central Islip, NY
Brand: Testosterone Cypionate
Manufacturer: Cipla USA Inc.
Classification: Class II
Status: Terminated
Recall initiated: 22 Mar 2019
FDA classified: 15 Apr 2019
Reported: 24 Apr 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Particulate Matter
Drug class: Injectable & IV Drugs

Timeline

22 Mar 2019	Recall initiated by company
15 Apr 2019	Classified by FDA	+24 days
24 Apr 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Presence of Particulate Matter.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the U.S.A.

Nationwide

Questions about this recall

Why was it recalled?

Presence of Particulate Matter.

Which lots are affected?

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.

Where was it sold?

Nationwide in the U.S.A.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 82463

This product is part of a recall event; the main page for the event is Testosterone Cypionate Injection, USP, 1000 mg/ (100 mg/mL) recalled.

Reported	Class	Recall	Company	Reason	Where
24 Apr 2019	CLASS II	Testosterone Cypionate Injection, USP, 1000 mg/ (100 mg/mL) recalledTestosterone Cypionate	InvaGen Pharmaceuticals	Particulate Matter	Nationwide
24 Apr 2019	CLASS II	Testosterone Cypionate Injection, USP, 200 mg/mL recalledTestosterone Cypionate	InvaGen Pharmaceuticals	Particulate Matter	Nationwide

More recalls from InvaGen Pharmaceuticals

All 11

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17 Jan 2024Drug	CLASS I	Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets recalledVigabatrin	InvaGen Pharmaceuticals	Packaging Defects	Nationwide
27 May 2020Drug	CLASS III	Gabapentin Tablets USP, 600 mg recalled by InvaGen PharmaceuticalsGabapentin	InvaGen Pharmaceuticals	Potency & Assay	Nationwide
10 Jul 2019Drug	CLASS III	Testosterone Topical Solution 30mg of testosterone per pump recalledTestosterone	InvaGen Pharmaceuticals	Other	Nationwide
24 Apr 2019Drug	CLASS II	Testosterone Cypionate Injection, USP, 200 mg/mL recalledTestosterone Cypionate	InvaGen Pharmaceuticals	Particulate Matter	Nationwide
24 Apr 2019Drug	CLASS II	Testosterone Cypionate Injection, USP, 1000 mg/ (100 mg/mL) recalledTestosterone Cypionate	InvaGen Pharmaceuticals	Particulate Matter	Nationwide

Other Testosterone Cypionate recalls

All 130

Reported	Class	Recall	Company	Reason	Where
21 May 2025Drug	CLASS II	Testosterone Cypionate Injection, 200 mg/mL, CIII recalled	Empower Clinic Services	Sterility	Nationwide
23 Apr 2025Drug	CLASS II	Testosterone Cypionate Injection, USP, CIII, 200mg per mL recalledTestosterone Cypionate	Eugia US	Manufacturing (CGMP) Deviations	Nationwide
12 Apr 2023Drug	CLASS II	Testosterone Cypionate Injection, USP, CIII, 200 mg/mL recalledTestosterone Cypionate	Azurity Pharmaceuticals	Manufacturing (CGMP) Deviations	Nationwide
20 Jul 2022Drug	CLASS II	Testosterone Cypionate/Enanthate 100/100mg/ml, a)-vial recalled	TMC Acquisition	Sterility	Nationwide
20 Jul 2022Drug	CLASS II	Testosterone Cypionate/Anastrozole 200mg/1mg/mL, a)-vial recalled	TMC Acquisition	Sterility	Nationwide