The Recall Desk
HighFDA (Drugs)·D-0536-2023·Announced 2023-04-26

Verapamil Hydrochloride Extended-Release Tablets Recalled for Failed Dissolution Specifications

Amerisource Health Services LLC is recalling Verapamil Hydrochloride Extended-Release Tablets 180 mg due to failed dissolution specifications affecting lots 1008622 and 1010026 distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for failed dissolution specifications without reported patient illnesses or injuries. The hazard represents a risk-of-harm product where medication delivery may be compromised, but actual patient harm has not been reported.

Plain-English summary

Amerisource Health Services LLC is recalling Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, because the tablets failed to meet dissolution specifications. This means tablets from the affected lots may not release medication at the intended rate.

The recall affects 695 cartons distributed nationwide in the USA under NDC Carton 60687-504-01 and NDC Unit Dose 60687-504-11. The affected lot numbers are 1008622 and 1010026, with an expiration date of February 29, 2024. The product was distributed by American Health Packaging of Columbus, Ohio.

Consumers who have received this medication should contact their healthcare provider or pharmacist with any questions about their medication.

The recalled product

Product
Verapamil Hydrochloride Extended-Release Tablets, USP, 180 mg, 100 Tablets (10 x 10) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-504-01; NDC Unit Dose: 60687-504-11, barcode (01) 003 60687 504 11 7.
Manufacturer
Amerisource Health Services LLC
Category
Drug
Hazard
  • dissolution-failure

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)

  • Lots: 1008622
  • 1010026
  • Exp 2/29/24

Distribution

Distributed nationwide across the United States.