The Recall Desk
LowFDA (Drugs)·D-1010-2019·Announced 2019-03-27

Lupin Recalls Testosterone Topical Solution Due to Pump Defects

Lupin Pharmaceuticals is recalling 3,200 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 FDA classified this as a Class III recall, 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 injury.

Plain-English summary

Lupin Pharmaceuticals Inc. is recalling 3,200 bottles of Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles. The product is identified by Lot # K700086 and has an expiration date of 11/2019. The recall is due to repetitive complaints indicating that the pump is not working.

The recalled product was distributed to 7 major wholesale/drug chain distributors and 1 supermarket chain, which may have further distributed the product throughout the United States. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on how to dispose of the medication or obtain a replacement.

The recalled product

Product
TESTOSTERONE (TESTOSTERONE)
Brand
TESTOSTERONE
Affected units
3,200

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 (2)

  • Lot # K700086
  • Exp 11/2019

Distribution

Distribution scope not specified by the agency.