Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets Recalled by Novel Laboratories, Inc. Due to Failed Impurities/Degradation Specifications
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 Novel Laboratories, Inc. directly.
Affected Products
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets, USP 5/1.5 mg Rx Only 30 Tablets Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 NDC 43386-118-03 UPC 343386118038
Quantity: 134,364 bottles (4,030,920 tablets)
Why Was This Recalled?
Failed Impurities/Degradation Specifications
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Novel Laboratories, Inc.
Novel Laboratories, Inc. has 3 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report