The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1124-2019·Announced 2019-04-24

InvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter

InvaGen Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because of the presence of particulate matter. The affected vials were distributed nationwide.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates temporary or medically reversible adverse health consequences. The hazard is particulate matter, which is a quality defect rather than a high-risk pathogen or structural defect, fitting the Moderate severity criteria for minor labeling or low-risk contamination issues.

Plain-English summary

InvaGen Pharmaceuticals, Inc. is recalling specific lots of Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Vial, Single Dose. The recall was initiated due to the presence of particulate matter in the product. The affected product is manufactured by Cipla Ltd. in India for Cipla USA, Inc.

The recall covers 692,538 vials distributed nationwide in the U.S.A. The specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring in December 2019, April 2020, May 2020, June 2020, July 2020, August 2020, and October 2020.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
Brand
TESTOSTERONE CYPIONATE
Manufacturer
InvaGen Pharmaceuticals, Inc.
Category
Drug — Injection
Hazard
Affected units
692,538

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

UPCs (3)

  • 0369097536374
  • 0369097537371
  • 0369097537319

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by InvaGen Pharmaceuticals, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same brand · TESTOSTERONE CYPIONATE

Same manufacturer · InvaGen Pharmaceuticals, Inc.

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Same hazard · particulate matter

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