InvaGen Recalls Testosterone Cypionate Injection Due to Particulate Matter
InvaGen Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because they contain particulate matter.
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 involves a temporary or medically reversible adverse health consequence. The hazard is particulate matter, which is a quality defect rather than a high-risk pathogen or structural failure, and no specific injuries or illnesses are reported in the source text.
Plain-English summary
InvaGen Pharmaceuticals, Inc. is recalling 12,234 vials of Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL). The product is a prescription-only, multiple-dose vial intended for intramuscular use. The recall covers specific lots with expiration dates ranging from January 2020 to August 2020.
The recall was initiated due to the presence of particulate matter in the product. The affected lots were distributed nationwide in the U.S.A. The product was manufactured by Cipla Ltd. in India for Cipla USA, Inc.
Consumers and healthcare providers should stop using the affected lots immediately. Patients should contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- InvaGen Pharmaceuticals, Inc.
- Category
- Drug — Injectable Steroid
- Hazard
- Affected units
- 12,234
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 #: 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
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
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