Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
9 recalls
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Class II Terminated
Kirkland Severe Cold & Flu Plus Congestion: Day – 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night – 56 coated caplets blister pack; (A…
Reason: CGMP Deviations: Released product should have been rejected.
Lots, distribution and details
- Product
- Kirkland Severe Cold & Flu Plus Congestion: Day – 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night – 56 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Doxylamine succinate 6.25 mg, Phenylephrine HCl 5 mg); Manufactured BY: LNK International, Inc. FOR: Costco Wholesale Corporation. NDC# 63981-795-81
- Lots / codes
- Lot # P139953, exp. date 2026/AUG Lot # P139815, exp. date 2026/AUG
- Distribution
- Product was distributed to 1 wholesale retail customer who may have further distribute the product nationwide.
- Quantity
- 288 cases x 30 8,640 boxes
- Recall started
- November 14, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0115-2025
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Class II Terminated
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7134-70
Reason: Failed Impurity/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot #: C00113, Exp. Date 11/2024; C00125, Exp. Date 04/2025; C00145, Exp. Date 07/2025
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- November 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0050-2025
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Class II Terminated
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
Reason: Failed Impurity/Degradation Specifications
Lots, distribution and details
- Lots / codes
- Lot #: C00128, Exp. Date 04/2025; C00146, Exp.Date 07/2025
- Distribution
- Nationwide within the United States
- Quantity
- N/A
- Recall started
- November 7, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0049-2025
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Class III Ongoing
Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code#…
Reason: Crystallization: Lack of uniformity – a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Lots, distribution and details
- Product
- Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code# 850015736018
- Lots / codes
- Lot#: 0813V, Exp 06/2025; 0103V, Exp 03/2025
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Quantity
- 105,048 bottles
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0034-2025
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Class III Ongoing
Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code #…
Reason: Crystallization: Lack of uniformity – a change in texture, chunky, grainy, and small crystal substances inside the bottles.
Lots, distribution and details
- Product
- Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa Inc., Alanta, GA, 30318, NDC-69676-0077-9, UPC Code # 850015736155
- Lots / codes
- Lot# 0104V, Exp 07/2025; 0106V, Exp 09/2024
- Distribution
- Product was distributed to two accounts that may have distributed the product further to the Retail Level.
- Quantity
- 72,648 bottles
- Recall started
- September 25, 2024 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0033-2025
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Class I Terminated
Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Reason: Microbial Contamination of Non-Sterile Products
Lots, distribution and details
- Lots / codes
- a) Lot#: T10810, Exp 10/31/2025 b) Lot#: T08730, T08731, T08732, T08733, Exp 05/31/2025; T10808, Exp 09/30/2025
- Distribution
- USA nationwide
- Quantity
- a) 31,632 bottles; b) 336,528 bottles
- Recall started
- December 26, 2023 (Voluntary: Firm initiated)
- Severity
- Most serious: use could cause serious health problems or death.
- FDA recall number
- D-0316-2024
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Class II Ongoing
Premier Value Tussin Cough DM, Dextromethorphan HBr…Cough Suppressant, Guaifenesin…Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA…
Reason: CGMP Deviations: Firm reported possible microbial contamination in the purified water used in the manufacturing of the products. No contamination was found in the final products.
Lots, distribution and details
- Product
- Premier Value Tussin Cough DM, Dextromethorphan HBr…Cough Suppressant, Guaifenesin…Expectorant, Alcohol Free, 8 FL OZ (237 mL) bottle, Distributed by: Pharmacy Value Alliance, LLC, 407 East Lancaster Avenue, Wayne PA 19087, UPC 8-40986-03789-4.
- Lots / codes
- Lot # SD23033, Exp 04/30/2025
- Distribution
- MI, PA
- Quantity
- 4,176 bottles
- Recall started
- December 28, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0215-2024
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Class II Ongoing
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Lots, distribution and details
- Lots / codes
- Lot 8639, Exp: 8/2023
- Distribution
- Product was distributed Nationwide.
- Quantity
- 13,968 bottles
- Recall started
- May 3, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0775-2023
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Class II Ongoing
Safe tussin DM, DAY TIME Cough Relief, (Dextromethorphan HBr, USP 10mg Guaifenesin, USP 100mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Reason: CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Lots, distribution and details
- Lots / codes
- Lot: 8314, Exp: 04/2023, 8753, 8753A, Exp: 10/2023; 8659, Exp: 08-2023
- Distribution
- Product was distributed Nationwide.
- Quantity
- 86,616 4 OZ bottles
- Recall started
- May 3, 2023 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0772-2023
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.