Cold Medicine Recalled Over Child Safety Packaging Violation

Roughly 14,250 units of an over-the-counter cold and flu medication have been recalled due to packaging that fails to meet federal child-resistant standards. Kramer Laboratories issued the recall for its Safetussin Max Strength Multi-Symptom Cough, Cold and Flu tablets after determining the blister packs pose a risk of child poisoning. The product contains acetaminophen, which under U.S. regulations must be sold in packaging that resists access by children. The current packaging allows tablets to be pushed through foil, creating a potential ingestion hazard.

The recall, announced April 10, 2025, applies to 24-count caplet blister packs sold under the Safetussin brand. These packs were distributed nationally at regional grocery stores including HEB and Harris-Teeter, as well as various independent pharmacies. Sales occurred between July 2024 and March 2025, with retail prices averaging around $11. The affected product is marketed as being safe for adults with high blood pressure and diabetes and comes in packaging with blue, orange, and red coloration.

No injuries or incidents have been reported in connection with the recalled medicine. However, as a precaution, consumers are advised to secure the product out of reach of children and contact Kramer Laboratories to arrange for a return or safe disposal. Refunds will be provided. Although the medication itself is not defective, the packaging’s non-compliance with the Poison Prevention Packaging Act necessitated the recall.

The medicine was distributed by Kramer Laboratories, a subsidiary of Arcadia Consumer Healthcare based in Bridgewater, New Jersey. The product was manufactured in India. Consumers seeking more information can reach the company by phone, email, or by visiting the official recall webpage at safetussin.com/recall.

Article by multiple RFHC contributors, based upon information from a U.S. Consumer Product Safety Commission press release.

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