Arbor Pharmaceuticals Recalls Testosterone Cypionate Injection Due to Labeling Error
Arbor Pharmaceuticals is recalling specific lots of Testosterone Cypionate Injection because shipper cartons were mislabeled, potentially causing confusion with different vial sizes.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the product is not likely to cause adverse health consequences. The issue is a packaging labeling error rather than a contamination or dosage defect.
Plain-English summary
Arbor Pharmaceuticals Inc. is recalling 67,934 units of Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose. The recall affects lots 23803.002B (Exp 07/2020) and 23803.005A (Exp 01/2021). The product was manufactured for Wilshire Pharmaceuticals, Inc. and distributed nationwide in the US.
The recall was initiated due to a labeling mix-up. Shipper cartons labeled for 1 mL single-dose vials were found to contain shelf cartons labeled for 10 mL multi-dose vials, which actually contained the 1 mL single-dose vials. This discrepancy in packaging labels could lead to confusion regarding the product contents.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the distributor or pharmacy for credit. Patients should consult their healthcare provider if they have questions about the medication.
The recalled product
- Product
- TESTOSTERONE CYPIONATE (TESTOSTERONE CYPIONATE)
- Brand
- TESTOSTERONE CYPIONATE
- Manufacturer
- Arbor Pharmaceuticals Inc.
- Category
- Drug — Prescription Injection
- Hazard
- Affected units
- 67,934
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 (4)
- lot# 23803.002B
- Exp 07/2020
- 23803.005A
- Exp 01/2021
Distribution
Distributed nationwide across the United States.
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