Cold Relief Drug Recalled for Manufacturing Deviations
Ultra Seal Corporation is recalling 227,010 packets of Cold Relief Severe Pain/Cough due to cGMP deviations. The recall affects Lot #AK9436 (expiration 01/2022) distributed nationwide.
What this means for you
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 is an FDA Class II recall for cGMP deviations. The source text does not report any illnesses, injuries, or deaths. Manufacturing deviations are process-integrity issues rather than direct safety hazards with reported harm, placing this in the Moderate category per the rubric.
Plain-English summary
Ultra Seal Corporation is recalling Cold Relief Severe Pain/Cough tablets containing acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, and phenylephrine HCl 5mg. The product was distributed in 2-tablet packets and manufactured for Select Corporation in Carrollton, Texas.
The recall was initiated due to cGMP (current good manufacturing practice) deviations identified by the manufacturer. This is a voluntary recall initiated by the firm. The affected lot is #AK9436 with an expiration date of 01/2022. A total of 227,010 packets were distributed nationwide within the United States.
Consumers who have purchased this product should stop using it. Consult a healthcare provider if you have taken this medication and have health concerns. The FDA classified this as a Class II recall. The recall was terminated on October 16, 2023.
The recalled product
- Product
- Cold Relief Severe Pain/Cough (acetaminophen 325mg, Dextromethorphan HBr 15mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
- Manufacturer
- Ultra Seal Corporation
- Affected units
- 227,010
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 (2)
- Lot #: AK9436
- Exp. Date 01/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 56 recalled by Ultra Seal Corporation 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 56 products in this recall →Related recalls
Same manufacturer · Ultra Seal Corporation
See all →- ModeratePEPTIME Energy Caffeine Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExaprin Pain Reliever Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateCold Terminator decongestant recalled for cGMP deviations
FDA (Drugs) · 2022-02-09
- ModerateLite Remfresh Melatonin Tablets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
- ModerateExtra Strength Un-Aspirin Acetaminophen Packets Recalled for cGMP Deviations
FDA (Drugs) · 2022-02-09
Same hazard · manufacturing deviation
See all →- SevereBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Vancomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateSynjardy XR Tablets Recalled Due to Manufacturing Deviations
FDA (Drugs) · 2026-07-08
- ModerateDuloxetine delayed-release capsules recalled for N-nitroso impurity contamination
FDA (Drugs) · 2026-05-13
- ModerateFentanyl Citrate Injectable Solution Recalled for cGMP Deviations
FDA (Drugs) · 2026-05-06