The Recall Desk
HighFDA (Drugs)·D-244-2013·Announced 2013-04-17

GSMS Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Particulates

GSMS Inc. is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they contain minute stainless steel particulates.

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: The recall involves a risk-of-harm product (foreign substance in medication) where injury has not yet been reported, aligning with the 'High' severity criteria.

Plain-English summary

GSMS Inc. is recalling specific lots of Lisinopril and Hydrochlorothiazide Tablets, USP, 20 mg/25 mg. The recall involves 100-count and 1,000-count bottles distributed nationwide. The affected product is prescription-only.

The recall was initiated after the manufacturer identified gray smudges in the tablets. These smudges were determined to be minute stainless steel particulates. The source text does not report any illnesses or injuries associated with this contamination.

Consumers with these specific products should stop using them and contact their healthcare provider or pharmacist for guidance. The affected NDCs are 60429-046-01 and 60429-046-10. Specific lot numbers and expiration dates are listed in the official recall notice.

The recalled product

Product
LISINOPRIL AND HYDROCHLOROTHIAZIDE TABLETS, USP, 20 mg/25 mg, 100 (NDC 60429-046-01) and 1,000 (NDC 60429-046-10) count bottles, Rx only, GSMS Inc., Camarillo, CA
Manufacturer
Gsms
Category
Drug — Prescription Medication
Hazard
Affected units
6,158

Distribution

Distributed nationwide across the United States.

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