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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

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Drug Recall Terminated Historical recordClass II

TG 40PSE/400GFN Tablets, 1000 count bottle, OTC Manufactured by: TG United, Inc. Brooksville, FL 34604 NDC 29273-0706-10

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

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Drug Recall Terminated Historical recordClass II

Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355, NDC 50991-561-60

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

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Drug Recall Terminated Historical recordClass II

Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

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Drug Recall Terminated Historical recordClass II

Lusair Liquid, 1 PINT bottle, OTC, Marketed by: Pernix Therapeutics, Gonzales, LA 70737 NDC 23359-017-16

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

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Drug Recall Terminated Historical recordClass II

BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58605-151-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

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Drug Recall Terminated Historical recordClass II

BroveX PSB LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-150-01 b) 20 ml NDC 58605-150-02, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

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Drug Recall Terminated Historical recordClass II

BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Cardec Drops,Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-604-30

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Dallergy CHEWABLE TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-152-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

Dallergy TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Laser Pharmaceuticals, LLC, Greenville, SC 29615, NDC 16477-160-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Drug Recall Terminated Historical recordClass II

NoHist TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Distributed by: Larken Laboratories, Inc., Canton, MS 39046, NDC 68047-173-01

by TG United, Inc.

Reason: CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
Recall initiated: January 30, 2013
Reported by FDA: June 12, 2013
Distribution: FL, MS, SC, LA and TX

View recall →

Data last updated: October 3, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.