TG United, Inc.: 44 FDA recall reports
Every drug recall the FDA has published for TG United, Inc.. The fault, and how the agency graded it.
44Reports
0Class I
0Ongoing
2013-06-12Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactu
D-509-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 2CPM/15DM/5PEH, Antihistamine, Nasal Decongestant, Fruit Candy Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0228-16.
- Where it went
- FL, MS, SC, LA and TX
- How much
- 355 - 16 ounce bottles
CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Tr
D-534-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- CPM / PSE DM Drops, Antihistamine, Cough Suppressant Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-072-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 26,315 - 30 mL bottles.
Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Ph
D-521-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Cardec DM Drops, Decongestant, Antihistamine, Antitussive, 1 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-550-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 216,838 bottles - 30 mL
Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuti
D-529-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Poly Hist Forte, Nasal Decongestant, Antihistamine, 100 count bottle, OTC, Manufactured for: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-210-01
- Where it went
- FL, MS, SC, LA and TX
- How much
- 330158 Bulk tablets.
Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Labora
D-535-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Mesehist DM, Antihistamine, Antitussive, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0085-16
- Where it went
- FL, MS, SC, LA and TX
- How much
- 12,120 - 16 ounce bottles
BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bott
D-519-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- BROMPHENIRAMINE/PSEUDOEPHEDRINE DM, LIQUID, Antihistamine, Cough Suppressant, Decongestant, 16 fl oz. bottle, OTC, Manufactured for: Macoven Pharmaceuticals, Magnolia, TX 77354 NDC 44183-311-16
- Where it went
- FL, MS, SC, LA and TX
- How much
- 22,721 - 16 ounce bottles
BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pern
D-525-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- BroveX PSE DM, Antihistamine, Cough Suppressant, Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-441-01
- Where it went
- FL, MS, SC, LA and TX
- How much
- 16,836 bottles - 100-count.
AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for:
D-508-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 25CPD/200GFN, Antitussive, Expectorant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0221-16.
- Where it went
- FL, MS, SC, LA and TX
- How much
- 348 - 16 ounce bottles.
Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: T
D-543-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Z-Dex Pediatric Drops, Cough Suppressant Decongestant, Expectorant 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0001-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 12,988 - 30 mL bottles.
AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manu
D-503-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 15DM/100GFN/5PEH, Antitussive, Expectorant, Nasal Decongestant, Grape Flavor, 4 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0200-04
- Where it went
- FL, MS, SC, LA and TX
- How much
- 1398 - 4 ounce bottles
AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottl
D-506-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 12.5 CPD/100GFN/30PSE, Antitussive, Expectorant, Nasal Decongestant, Raspberry Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0223-16
- Where it went
- FL, MS, SC, LA and TX
- How much
- 348 - 16 ounce bottles
ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharma
D-515-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- ED A-HIST TABLETS, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Edwards Pharmaceuticals Inc., Ripley, MS 38663, NDC 0485-0154-01
- Where it went
- FL, MS, SC, LA and TX
- How much
- 242,470
Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by
D-530-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Poly-Vent DM Tablets, Cough Suppressant, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Poly Pharmaceuticals, Quitman, MS 39355 NDC 50991-309-60
- Where it went
- FL, MS, SC, LA and TX
- How much
- 977,719 Bulk Tablets
ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trige
D-545-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- ZoDen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0080-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 39,801 - 30 mL bottles.
Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceutic
D-523-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Maxifed-G, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. Brooksville, FL 34604, NDC 58605-0408-01
- Where it went
- FL, MS, SC, LA and TX
- How much
- 1623 bottles of 100-count tablets.
ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayr
D-546-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- ZoDen PD, Antihistamine, Nasal Decongestant,16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872 NDC 13811-0073-16
- Where it went
- FL, MS, SC, LA and TX
- How much
- 4811 - 16 ounce bottles.
AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl
D-507-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 12.5 CPD/120GFN/5PEH, Cough Suppressant, Expectorant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0224-16
- Where it went
- FL, MS, SC, LA and TX
- How much
- 348 - 16 ounce bottles
CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratori
D-533-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- CPM / PSE Drops, Antihistamine, Nasal Decongestant, 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-071-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 6551 30 mL bottles
Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laborator
D-544-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Z-Dex Syrup, Decongestant, Antitussive, Expectorant, 16 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0002-16
- Where it went
- FL, MS, SC, LA and TX
- How much
- 2388 - 16 ounce bottles.
AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactur
D-512-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 40PSE/400GFN/20DM, Cough Suppressant, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0409-01
- Where it went
- FL, MS, SC, LA and TX
- How much
- 1772 bottles per 100 count each
Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayre
D-541-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Trigofen Drops, Antihistamine, Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ, 08872, NDC 13811-0081-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 39,403 - 30 mL bottles
TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratorie
D-539-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- TL-Hist PD Drops, Antihistamine, Nasal Decongestant,1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-083-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 13,031 30 mL bottles.
AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl
D-510-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 3BRM/15DM/30PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0230-16.
- Where it went
- FL, MS, SC, LA and TX
- How much
- 348 - 16 ounce bottles
Poly-Vent IR, Poly-Vent DM Tablets, Expectorant, Nasal Decongestant, 60 count bottle, OTC, Distributed by: Pol
D-531-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- 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
- Where it went
- FL, MS, SC, LA and TX
- How much
- 978,092 Bulk Tablets
BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, G
D-524-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- BroveX PSE, Antihistamine, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: Pernix Therapeutics, Gonzales, LA 70737 NDC 58605-440-01
- Where it went
- FL, MS, SC, LA and TX
- How much
- 10,036 bottles - 100-count tablets
BroveX PSB DM LIQUID, Antihistamine, Decongestant, a) 16 fl oz. bottle, OTC, NDC 58605-151-01 b) 20 ml NDC 58
D-527-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- 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
- Where it went
- FL, MS, SC, LA and TX
- How much
- 19,728 bottles - 20 mL and 20,016 bottles - 16 ounce.
Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuti
D-522-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Maxifed DM, Expectorant, Nasal Decongestant, 100 count bottle, OTC, Manufactured for: MCR American Pharmaceuticals Inc. , Brooksville, FL 34604, NDC 58605-0409-01
- Where it went
- FL, MS, SC, LA and TX
- How much
- 2706 bottles of 100 count tablets
AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl o
D-511-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- AMBI 3BRM/30DM/50PSE, Antihistamine, Cough Suppressant, Nasal Decongestant, Berry Vanilla Flavor, 16 fl oz. bottle, OTC, Manufactured for: AMBI Pharmaceuticals, Brooksville, FL 34604, NDC 66870-0229-16
- Where it went
- FL, MS, SC, LA and TX
- How much
- 348 - 16 ounce bottles
Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste
D-514-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Ryddex G Tablets, Decongestant, Expectorant, 100 count bottle, OTC, Centurion Labs, LLC 657 Hwy 40 South, Ste B, Richland, MS 39218, NDC 23359-024-10
- Where it went
- FL, MS, SC, LA and TX
- How much
- 2957 bottles 100-count tablets
Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: T
D-542-2013 · Class II · reported 2013-06-12 · Terminated
- Why it was recalled
- CGMP Deviations: Products are underdosed or have an incorrect dosage regime.
- Product
- Trigofen DM Drops, Antihistamine,Cough Suppressant, Decongestant, , 1 fl oz. bottle, OTC, Manufactured for: Trigen Laboratories, Sayreville, NJ,08872, NDC 13811-0082-30
- Where it went
- FL, MS, SC, LA and TX
- How much
- 40,149 - 30 mL bottles.
Showing the 30 most recent of 44. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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