The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-130-2013·Announced 2013-01-30

West-ward Recalls Lisinopril Tablets Due to Foreign Substance Presence

West-ward Pharmaceutical Corp. is recalling specific lots of Lisinopril Tablets, USP 40 mg, because uncharacteristic black spots were found in the tablets.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, an FDA Class II recall involving a foreign substance (stainless steel inclusions) in a drug product is categorized as Severe.

Plain-English summary

West-ward Pharmaceutical Corp. is recalling 32,550 bottles of Lisinopril Tablets, USP 40 mg. The affected products are packaged in 100-count and 1000-count bottles and are available by prescription only. The recall covers specific lots manufactured by West-ward Pharmaceutical Corp. and manufactured for Blu Pharmaceuticals.

The recall was initiated due to the presence of a foreign substance. Uncharacteristic black spots were identified in the tablets as a food-grade lubricant containing trace amounts of foreign particulates and stainless steel inclusions.

The affected products were distributed nationwide and in Puerto Rico. Patients and healthcare providers should discontinue use of the recalled lots and contact their healthcare provider for appropriate medical advice or alternative treatment.

The recalled product

Product
Lisinopril Tablets, USP 40 mg, packaged in a) 100-count tablets per bottle (NDC 0143-1270-01); b) 1000-count tablets per bottle (NDC 0143-1270-10); Rx only, Manufactured by: West-ward Pharmaceutical Corp., Eatontown, NJ 07724; and c) 1000-count tablets per bottle (NDC…
Manufacturer
West-ward Pharmaceutical Corp.
Category
Drug — Prescription Medication
Hazard
Affected units
32,550

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 (19)

  • Lot #: a) and b) 69545A
  • 69546A
  • 69546B
  • Exp 10/15
  • 69547A
  • Exp 11/15
  • 69995A
  • 69999A
  • 69999B
  • 70000A
  • 70001A
  • 70002A
  • 70002B
  • 70003A
  • 70004A
  • Exp 02/16
  • c) 69548A
  • 69549A
  • 69877A

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by West-ward Pharmaceutical Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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