Class III — Low Risk

Low risk — use of or exposure to this product is not likely to cause adverse health consequences.

GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT Recalled by Hi-Tech Pharmacal Co., Inc. Due to Subpotent; phenylephrine HCl

Date: September 4, 2013
Company: Hi-Tech Pharmacal Co., Inc.
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hi-Tech Pharmacal Co., Inc. directly.

Affected Products

GILTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 1 fl. oz. (NDC 58552-122-01) and 8 fl. oz. (NDC 58552-122-08), and EXACTUSS ANTITUSSIVE EXPECTORANT AND NASAL DECONGESTANT, 16 fl. oz. (NDC 58552-125-16) --- Manufactured for: GIL PHARMACEUTICAL CORP. PONCE, PUERTO RICO 00716

Quantity: 50,848 bottles (total for 3 lots)

Why Was This Recalled?

Subpotent; phenylephrine HCl

Where Was This Sold?

Puerto Rico

About Hi-Tech Pharmacal Co., Inc.

Hi-Tech Pharmacal Co., Inc. has 10 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report