TG United Recalls AMBI Cough Syrup Due to Underdosing
TG United, Inc. is recalling 348 bottles of AMBI cough syrup because the product is underdosed or has an incorrect dosage regime.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or health risks associated with dosage errors.
Plain-English summary
TG United, Inc. is recalling 348 16-ounce bottles of AMBI 3BRM/15DM/30PSE, an over-the-counter antihistamine, cough suppressant, and nasal decongestant in Berry Vanilla flavor. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the products are underdosed or have an incorrect dosage regime.
The affected product is identified by Lot # 12HQ003 and an expiration date of 07/14. The product was distributed in Florida, Mississippi, South Carolina, Louisiana, and Texas.
Consumers should stop using the product and return it to the place of purchase for a refund or contact the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- TG United, Inc.
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 # 12HQ003
- Exp. 07/14.
Distribution
Part of a larger recall action
This product is one of 44 recalled by TG United, Inc. 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 44 products in this recall →Related recalls
Same manufacturer · TG United, Inc.
See all →- SevereTG United Recalls Trigofen DM Drops Due to Underdosing
FDA (Drugs) · 2013-06-12
- SevereTG United Recalls Underdosed AMBI Antihistamine Nasal Decongestant Syrup
FDA (Drugs) · 2013-06-12
- ModerateTG United Recalls Underdosed AMBI Cough Suppressant and Expectorant
FDA (Drugs) · 2013-06-12
- SevereTG United Recalls Z-Dex Syrup Due to Underdosing and Incorrect Dosage
FDA (Drugs) · 2013-06-12
- ModerateTG United Recalls CPM PSE Drops Due to CGMP Deviations
FDA (Drugs) · 2013-06-12
Same hazard · underdosing
See all →- SevereBD Texium Closed System Drug Transfer Devices May Leak at Connector
FDA (Devices) · 2025-06-18
- HighBD TEXIUM Closed Male Luer Devices Recalled for Leaking Interface Risk
FDA (Devices) · 2025-06-18
- HighAlaris Pump Infusion Sets may leak at male luer connections
FDA (Devices) · 2025-06-18
- HighBD TEXIUM Closed Male Luer Drug Transfer Device Recall
FDA (Devices) · 2025-06-18
- HighBD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface
FDA (Devices) · 2025-06-18
Similar recalls
- ModerateMBi Homeopathic Expectorant Cough Syrup Recalled for Lack of Processing Controls
FDA (Drugs) · 2018-06-20
- HighSafe Tussin PM Night Time Cough Relief Recalled for Manufacturing Deviation
FDA (Drugs) · 2023-08-02
- ModerateMBi Nutraceuticals Recalls Homeopathic Nausea Drops Due to Manufacturing Controls
FDA (Drugs) · 2018-06-20
- ModerateMBi Nutraceuticals Recalls Stomach Calm and Other Homeopathic Products
FDA (Drugs) · 2018-06-20
- ModerateAlprazolam Tablets 2.0 mg Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-23
- ModerateMBi Homeopathic Teething Drops Recalled for Lack of Manufacturing Controls
FDA (Drugs) · 2018-06-20