Medications & Supplements/Prescription Drugs

Bryant Ranch Morphine Sulfate Extended-Release Tablets Recalled for Label Mix-up

Agency Publication Date: July 8, 2022

Summary

Bryant Ranch Prepack, Inc. is recalling two lots of Morphine Sulfate extended-release tablets (morphine sulfate) due to a labeling error. Bottles labeled as containing 60 mg tablets may actually contain 30 mg tablets, and bottles labeled as 30 mg may contain 60 mg tablets. This error occurred during the packaging process and affects 100-count bottles of both strengths. While no injuries have been reported, taking an incorrect dose of this medication poses a high risk to patient safety.

Risk

Consumers taking the 60 mg dose could accidentally receive the 30 mg strength, leading to inadequate pain control and potential withdrawal. Conversely, patients prescribed the 30 mg dose who receive the 60 mg strength are at risk of a life-threatening overdose.

What You Should Do

The recalled products are 100-count bottles of Morphine Sulfate extended-release tablets in 30 mg (Lot 179642, Exp 11/30/2023, NDC 63629-1088-01) and 60 mg (Lot 179643, Exp 08/31/2023, NDC 63629-1089-01) strengths.
Check your medication bottle for the lot numbers, National Drug Codes (NDC), and expiration dates listed above to determine if your supply is affected by this recall.
If you have health concerns or believe you have taken the incorrect dose, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact Bryant Ranch Prepack, Inc. directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report an adverse event.

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: Morphine Sulfate extended-Release Tablets, USP (100-count)

Variants: 30 mg, Tablet

Lot Numbers:

179642 (Exp 11/30/2023)

NDC:

63629-1088-01

GTIN:

00363629108817

Manufactured by Ohm Laboratories Inc.; Relabeled by Bryant Ranch Prepack, Inc.

Product: Morphine Sulfate extended-Release Tablets, USP (100-count)

Variants: 60 mg, Tablet

Lot Numbers:

179643 (Exp 08/31/2023)

NDC:

63629-1089-01

GTIN:

00363629108916

Manufactured by Ohm Laboratories Inc.; Relabeled by Bryant Ranch Prepack, Inc.

Product Images

Product image, 30mg tablets round, purple-colored

Product image, label 30mg

Product image, 60mg tablets round, light orange-colored

Product image, label 60mg

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90481

Status: Resolved

Manufacturer: Bryant Ranch Prepack, Inc.

Sold By: Wholesaler in AL

Manufactured In: United States

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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 · FDA Press Release · 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

The recalled products are 100-count bottles of Morphine Sulfate extended-release tablets in 30 mg (Lot 179642, Exp 11/30/2023, NDC 63629-1088-01) and 60 mg (Lot 179643, Exp 08/31/2023, NDC 63629-1089-01) strengths.

Check your medication bottle for the lot numbers, National Drug Codes (NDC), and expiration dates listed above to determine if your supply is affected by this recall.

If you have health concerns or believe you have taken the incorrect dose, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact Bryant Ranch Prepack, Inc. directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or need to report an adverse event.

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: Morphine Sulfate extended-Release Tablets, USP (100-count)

Variants: 30 mg, Tablet

Lot Numbers:

179642 (Exp 11/30/2023)

NDC:

63629-1088-01

GTIN:

00363629108817

Manufactured by Ohm Laboratories Inc.; Relabeled by Bryant Ranch Prepack, Inc.

Product: Morphine Sulfate extended-Release Tablets, USP (100-count)

Variants: 60 mg, Tablet

Lot Numbers:

179643 (Exp 08/31/2023)

NDC:

63629-1089-01

GTIN:

00363629108916

Manufactured by Ohm Laboratories Inc.; Relabeled by Bryant Ranch Prepack, Inc.