Class II · Moderate risk
CVS Health Children's Mucus Relief Chest Congestion Plus Cough…
CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.
Is Guaifenesin recalled?
Yes — there is an active recall. 7 ongoing FDA recalls mention Guaifenesin (78 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Guaifenesin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Guaifenesin recalls on record
none so far in 2026; 78 on record, newest first
Class II · Moderate risk
Ritussin DM Dextromethorphan Hydrobormide
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Class II · Moderate risk
Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant
Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Class I · High risk
Licorice Coughing Liquid
Marketed Without An Approved NDA/ANDA: presence of undeclared morphine.
Class II · Moderate risk
Guaifenesin DM Cherry liquid
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class II · Moderate risk
Guaifenesin Grape liquid 100 mg/5 mL
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Class I · High risk
Mucinex Fast Max Severe Congestion & Cough
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast-Max Cold & Sinus
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class I · High risk
Mucinex Fast Max Cold
Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenesin. As a result certain safety warnings associated with those ingredients may also be missing.
Class III · Low risk
Mucinex DM
Defective container: A customer complaint revealed the presence of a defective seal on the top of a Mucinex pouch
Class III · Low risk
Lortuss Ex
Does Not Meet Monograph: Phenylephrine and pseudoephedrine are below monograph specifications, and label inaccurately contains wording "Rx Only".
Class III · Low risk
Maximum Strength/Non-Drowsy Tussin DM Adult Maximum Strength
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles.
Class III · Low risk
Tussin CF Adult Maximum Strength Multi-Symptom Cold liquid
Presence of Precipitate: Recall is due to complaints of a white substance, confirmed as Guaifenesin, an active ingredient in the product which is precipitating out.
Class II · Moderate risk
Guaifenesin USP
Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin.
Class II · Moderate risk
guaiFENesin ER Tablet
Labeling:Label Mixup; guaiFENesin ER Tablet, 600 mg may be potentially mislabeled as OMEGA-3-ACID ETHYL ESTERS, Capsule, 1000 mg, NDC 00173078302, Pedigree: W003243, EXP: 6/17/2014.
Class II · Moderate risk
guaiFENesin ER Tablet
Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as PRENATAL MULTIVITAMIN/ MULTIMINERAL, Tablet, NDC 51991056601, Pedigree: AD62829_18, EXP: 5/24/2014; guaiFENesin ER, Tablet, 600 mg, NDC 63824000834, Pedigree: AD62834_4, EXP: 5/24/2014; diphenhydrAMINE HCl, Tablet, 25 mg, NDC 00904555159, Pedigree: W003513, EXP: 6/21/2014; DOCUSATE SODIUM, Capsule, 250 mg,
Class II · Moderate risk
guaiFENesin ER
Labeling:Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: AD21965_13, EXP: 5/1/2014; TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: AD56917_7, EXP: 5/21/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: AD73627_17, EXP: 5/30/2014; LACTOBACILLUS GG, Capsule, NDC 49100036374, Pedigree: W003216
Class II · Moderate risk
guaiFENesin ER Tablet
Labeling: Label Mixup; guaiFENesin ER, Tablet, 600 mg may be potentially mislabeled as FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: AD21790_52, EXP: 5/1/2014; FENOFIBRATE, Tablet, 54 mg, NDC 00378710077, Pedigree: W002733, EXP: 6/6/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: W003688, EXP: 5/31/2014; glyBURIDE, Tablet, 2.5 mg, NDC 00093834301, Pedigree: AD30140_34, E
Class II · Moderate risk
Guaifenesin
Labeling: Label Mixup; GUAIFENESIN, Tablet, 200 mg may be potentially mislabeled as PANCRELIPASE DR, Capsule, 24000 /76000 /120000 USP units, NDC 00032122401, Pedigree: W002850, EXP: 6/7/2014.
Class II · Moderate risk
Theraflu Flu & Chest Congestion
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Theraflu MAX-D Severe Cold & Flu
Presence of Foreign Substance: The products are being recalled because they may contain foreign substances.
Class II · Moderate risk
Pentrexcilina Jarabe NF
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
Class III · Low risk
Rite Aid brand Maximum Strength Tussin Cough & Cold Mucus Relief CF
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Wal-Mart Equate Tussin CF Adult Maximum Strength
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
Class III · Low risk
Select Brand Cough Control CF Max
Presence of Precipitate; white substance confirmed as Guaifenesin, an active ingredient was observed in some bottles. If the product is shaken or warmed the white particles goes into the solution.
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