Extra Strength Headache tablets recalled for CGMP manufacturing deviations
Medique Products is recalling Extra Strength Headache tablets nationwide after an FDA inspection found they were not manufactured under Current Good Manufacturing Practices.
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 involving CGMP manufacturing deviations. The source text does not report any illnesses, injuries, or confirmed product defects—only a process violation identified during inspection. Under the rubric, manufacturing process violations without reported harm are typically classified as Moderate.
Plain-English summary
Medique Products is recalling Extra Strength Headache tablets (containing acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) packaged in 2-count packets, manufactured for Lil' Drug Store Products, Inc. The recall affects approximately 6,639,838 tablets distributed nationwide in the USA across 12 lots with expiration dates ranging from June 2022 to June 2023.
The recall was initiated after an FDA inspection determined that these products were not manufactured under Current Good Manufacturing Practices (CGMP), which are regulatory requirements ensuring product quality and safety.
Consumers who have purchased this product should stop using it and contact Medique Products or their retailer for further instructions.
The recalled product
- Product
- Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
- Manufacturer
- Medique Products
- Hazard
- cgmp-deviation
- manufacturing-defect
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 (12)
- Lots: 6492 Exp. 06/2022
- 6701 Exp. 10/2022
- 6750 Exp. 12/2022
- 6853 Exp. 01/2023
- 6854 Exp. 01/2023
- 6869 Exp. 02/2023
- 6898 Exp. 02/2023
- 6901 Exp. 02/2023
- 7059 Exp. 05/2023
- 7060 Exp. 05/2023
- 7064 Exp. 06/2023
- 7065 Exp. 06/2023
Distribution
Distributed nationwide across the United States.
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