The Recall Desk
LowFDA (Drugs)·D-0087-2019·Announced 2018-10-31

Lupin Recalls Testosterone Topical Solution Due to Defective Pump

Lupin Pharmaceuticals is recalling 6,752 bottles of Testosterone Topical Solution because the pump mechanism is not working.

What this means for you

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 by definition is unlikely to cause adverse health consequences. The issue is a mechanical defect (pump not working) rather than a safety hazard like contamination or mislabeling.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling 6,752 bottles of Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles. The product is a prescription-only medication manufactured for Lupin Pharmaceuticals Inc. in Baltimore, Maryland, and manufactured by Lupin Limited in India. The affected product is identified by NDC 68180-943-11 and includes lots K700085 and K700087 with an expiration date of November 2019.

The recall was initiated due to repetitive complaints indicating that the pump mechanism on the bottles is not working. This defect affects the ability to dispense the medication properly. The product was distributed nationwide within the United States.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment. The recall is classified as Class III by the FDA, indicating that the defect is not likely to cause adverse health consequences.

The recalled product

Product
TESTOSTERONE (TESTOSTERONE)
Brand
TESTOSTERONE
Affected units
6,752

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 (3)

  • Lot #: K700085
  • K700087
  • Exp. November 2019

Distribution

Distributed nationwide across the United States.