Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1228-2015·Announced 2015-07-15

American Health Packaging Recalls Lisinopril Tablets Due to CGMP Deviations

American Health Packaging is recalling 5,591 cartons of Lisinopril 20mg tablets nationwide because the firm did not adequately investigate customer complaints.

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 2/5 (Moderate).

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 due to CGMP deviations (inadequate complaint investigation) without reported illnesses or injuries, fitting the 'Moderate' criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

American Health Packaging is recalling 5,591 cartons of Lisinopril tablets, USP 20mg, packaged in 10-count blisters. The affected product is identified by NDC 68084-062-11 (blister) and NDC 68084-062-01 (carton), with Lot # 131934 and an expiration date of 09/30/2015. The tablets are manufactured by Wockhardt Limited in Mumbai, India, and distributed by Wockhardt, USA, LLC in Parsippany, NJ, for American Health Packaging in Columbus, OH.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, the firm did not adequately investigate customer complaints. This is a Class II recall, indicating a violation of CGMPs that may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDC, lot number, and expiration date listed above. If found, the product should be returned to the pharmacy or distributor for a refund or replacement.

The recalled product

Product: Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for…
Manufacturer: American Health Packaging
Category: Drug — Prescription Medication
Hazard: cgmp-deviation
quality-control
Affected units: 5,591

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#: 131934
Exp 09/30/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 13 recalled by American Health Packaging 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 13 products in this recall →

Same manufacturer · American Health Packaging

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