Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hydrocodone Bitartrate and Acetaminophen Oral Solution Recalled by Mallinckrodt Inc. Due to CGMP Deviations: This product is being recalled because...
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: 44,330 bottles
Why Was This Recalled?
CGMP Deviations: This product is being recalled because expired flavoring was used in the manufacturing of these lots.
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