Guaifenesin-Dextromethorphan Cough Syrup Recalled for Failed Impurity Specifications
Major Pharmaceuticals is recalling Guaifenesin Dextromethorphan Syrup nationwide for specific lots that failed to meet impurity and degradation specifications. Consumers should contact their pharmacist if they possess affected lots.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification indicates potential for serious adverse health consequences. However, no illnesses or injuries have been reported, and the specific impurities and their risks are not identified in the source. Per the rubric, when no illnesses are reported and the hazard is theoretical, the maximum score is 3.
Plain-English summary
The Harvard Drug Group LLC, operating as Major Pharmaceuticals and Rugby Laboratories, is recalling Guaifenesin Dextromethorphan Syrup (200 mg/20 mg per 10 mL, NDC 0904-7135-72) nationwide. The affected lots are C00128 (expiration 04/2025) and C00146 (expiration 07/2025).
The product is being recalled because these lots failed to meet FDA specifications for impurity and degradation. This means the product did not maintain required standards for chemical purity and stability during its shelf life.
Consumers who have purchased this cough syrup should check their bottles for Lot C00128 or Lot C00146. Do not use the product if you have one of these affected lots.
Contact your pharmacist or healthcare provider if you have questions about this recall or believe you have been affected. For additional information, visit the FDA's drug safety website.
The recalled product
- Product
- Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Category
- Drug — Cough/Cold Syrup
- Hazard
- impurity
- degradation
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 (4)
- Lot #: C00128
- Exp. Date 04/2025
- C00146
- Exp.Date 07/2025
Distribution
Distributed nationwide across the United States.
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