The Recall Desk
ModerateFDA (Drugs)·D-1406-2015·Announced 2015-09-09

Qualitest Recalls Lisinopril Tablets for Failed Dissolution Specifications

Vintage Pharmaceuticals is recalling 8,705 bottles of Lisinopril 40 mg tablets because they failed dissolution specifications. The affected lots were distributed nationwide and in Puerto Rico.

What this means for you

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 is reasonably likely to cause temporary or medically reversible adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality defect rather than a contamination or mislabeling issue involving high-risk pathogens or allergens.

Plain-English summary

Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals is recalling 8,705 bottles of Lisinopril Tablets, USP, 40 mg. The recall involves 45-count bottles (NDC 0603-4214-60) and 500-count bottles (NDC 0603-4214-28). The specific lots affected are C0570215B and C0570215A, both with an expiration date of 02/17.

The reason for the recall is that the tablets failed to meet dissolution specifications. Dissolution is a critical quality attribute that ensures the medication breaks down and releases the active ingredient in the body as intended. If a tablet does not dissolve properly, it may not provide the expected therapeutic effect.

The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed above. If the product is found, it should be returned to the pharmacy or supplier for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Lisinopril Tablets, USP, 40 mg, a) 45-count bottle (NDC 0603-4214-60), b) 500-count bottle (NDC 0603-4214-28), Rx Only, Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811
Manufacturer
Vintage Pharmaceuticals LLC dba Qualitest Pharmaceuticals
Category
Drug — Prescription Medication
Hazard
Affected units
8,705

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 # a) C0570215B
  • Exp 02/17 b) C0570215A
  • Exp 02/17

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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