Safe Tussin DM Cough Suppressant Recalled for Manufacturing Deviation
Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This FDA Class II recall is based on a manufacturing deviation without reported illnesses or injuries. The use of non-food grade lubricant represents a precautionary manufacturing quality issue rather than a confirmed contamination or documented health harm.
Plain-English summary
Kramer Laboratories, Inc. is recalling Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/Guaifenesin), a 4.0 FL OZ (118 mL) liquid cough suppressant and expectorant, due to a Current Good Manufacturing Practice (CGMP) deviation.
The deviation involves the use of a non-food grade lubricant in the mixing vessel during the manufacturing process. Affected lot numbers are 8753, 8753A (both with expiration date 10/2023) and 8659 (expiration date 8/2023).
The product was distributed nationwide throughout the United States. Consumers who have purchased this medication in the affected lots should discontinue use and contact Kramer Laboratories or consult with their healthcare provider if they have questions or concerns.
The recalled product
- Product
- Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
- Manufacturer
- Kramer Laboratories, 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 (3)
- Lot #: 8753
- 8753A
- Exp. Date 10/2023 Lot #: 8659 Exp. Date 8/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Kramer Laboratories, 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 2 products in this recall →Related recalls
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