Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Hydrocodone Bitartrate and Acetaminophen Oral Solution Recalled by Mallinckrodt Inc. Due to Subpotent (Multiple Ingredient) Drug: Low out of specification...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Mallinckrodt Inc. directly.
Affected Products
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/500 mg per 15 mL, 16 fl oz (473 mL) bottle, Rx only, Mallinckrodt Inc., Hazelwood, MO 63042 USA, NDC 0406-0375-16, UPC 3 0406-0375-16 1.
Quantity: 41,100 bottles
Why Was This Recalled?
Subpotent (Multiple Ingredient) Drug: Low out of specification assay results for the hydrocodone bitartrate ingredient was found.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Mallinckrodt Inc.
Mallinckrodt Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report