Lupin Somerset Hydrocodone Bitartrate and Acetaminophen Recall

Why it was recalled

Labeling: Missing Label

Product description

Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102

Lot numbers, UPCs & expiration codes

Lot # S800257; Exp. 01/20

Where it was sold

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0836-2018
Classification: Class III
Status: Terminated
Recall initiated: May 24, 2018
FDA report date: Jun 6, 2018
Quantity: 1,672 (1000-count) bottles
Recall type: Voluntary: Firm initiated
Recalling firm: LUPIN SOMERSET

Original FDA data

Every field from FDA enforcement report D-0836-2018, exactly as published.

Show all FDA fields

City: Somerset
State: NJ
Status: Terminated
Country: United States
Event ID: 80187
Address: 400 Campus Dr
Code information: Lot # S800257; Exp. 01/20
Postal code: 08873-1145
Report date: Jun 6, 2018
Product type: Drugs
Recall number: D-0836-2018
Classification: Class III
Recalling firm: LUPIN SOMERSET
Product quantity: 1,672 (1000-count) bottles
Termination date: Jan 26, 2021
Reason for recall: Labeling: Missing Label
Voluntary / mandated: Voluntary: Firm initiated
Product description: Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
Distribution pattern: OH
Recall initiation date: May 24, 2018
Initial firm notification: Letter
Center classification date: May 31, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0836-2018, published Jun 6, 2018. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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