Guaifenesin Dextromethorphan Syrup recall
FDA recall D-0049-2025 · initiated Nov 7, 2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Guaifenesin Dextromethorphan Syrup in Nov 2024 — an FDA Class II recall (D-0049-2025) because Failed Impurity/Degradation Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Impurity/Degradation Specifications
An impurity above the accepted limit
A by-product of manufacturing or storage exceeded the limit the FDA accepts. Nitrosamines are the common example: the concern is long-term exposure, not immediate danger from one dose.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: N/A
Details
- Product
- Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC 0904-7135-72
- Recalling company
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the United States
- Initiated
- Nov 7, 2024
- FDA report date
- Nov 27, 2024
Frequently asked
- Was Guaifenesin Dextromethorphan Syrup recalled?
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalled Guaifenesin Dextromethorphan Syrup in Nov 2024 — an FDA Class II recall (D-0049-2025) because Failed Impurity/Degradation Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Guaifenesin Dextromethorphan Syrup recalled?
- Per the FDA enforcement record, the reason for recall D-0049-2025 was: Failed Impurity/Degradation Specifications
- Is a recalled Guaifenesin Dextromethorphan Syrup dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Guaifenesin Dextromethorphan Syrup are affected?
- Distributed: Nationwide within the United States. The recall covers these lots — Lot #: C00128, Exp. Date 04/2025; C00146, Exp.Date 07/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0049-2025.