Medications & Supplements/Prescription Drugs

ScieGen Gabapentin 600 mg Tablets Recalled for Comingled 800 mg Tablets

Agency Publication Date: February 27, 2023

Summary

ScieGen Pharmaceuticals Inc. is recalling 4,392 bottles of Gabapentin (600 mg), a prescription medication used to treat seizures and nerve pain, because 800 mg tablets were found mixed into the 600 mg bottles. The recall affects 500-count bottles with NDC 50228-177-05 and lot number G177092. No injuries or adverse events have been reported to date regarding this comingling.

Risk

Patients may unintentionally take a higher dose of medication than prescribed (800 mg instead of 600 mg), which can lead to an increased risk of side effects or adverse reactions.

What You Should Do

This recall affects ScieGen Pharmaceuticals Gabapentin 600 mg Tablets sold in 500-count bottles with NDC 50228-177-05, lot number G177092, and an expiration date of 11/24.
Check the label of your prescription bottle to identify if it matches lot number G177092 and expiration date 11/24.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact ScieGen Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Gabapentin Tablets, USP 600 mg (500 count bottle)

Variants: 600 mg, Tablet

Lot Numbers:

G177092 (Exp 11/24)

NDC:

50228-177-05

Pharmacist reported presence of some Gabapentin tablets 800 mg comingled in Gabapentin 600 mg bottles.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 91717

Status: Resolved

Manufacturer: Sciegen Pharmaceuticals Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 4,392 bottles

Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects ScieGen Pharmaceuticals Gabapentin 600 mg Tablets sold in 500-count bottles with NDC 50228-177-05, lot number G177092, and an expiration date of 11/24.

Check the label of your prescription bottle to identify if it matches lot number G177092 and expiration date 11/24.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact ScieGen Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.