Morphine Sulfate Tablets Recalled for Label Mix-up Dosage Error
Morphine Sulfate extended-release tablets (30 mg) distributed in Alabama were recalled due to a critical label mix-up where bottles labeled as 60 mg contain 30 mg, and bottles labeled as 30 mg may contain 60 mg.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall. Per the rubric, FDA Class I recalls must score at least 4. The dosage labeling error creates serious risk of medication error with extended-release opioid products, though no illnesses or injuries are reported in the source.
Plain-English summary
Morphine Sulfate extended-release tablets, 30 mg, 100-count bottles manufactured by Ohm Laboratories Inc. and relabeled by Bryant Ranch Prepack, Inc. have been recalled due to a critical label mix-up.
The affected bottles were labeled incorrectly: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets actually contain Morphine Sulfate 30 mg Extended-Release tablets, and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets. This dosage labeling error creates a risk of medication error and potential harm to patients.
The recalled product (Lot #179642, Expiration Date 11/30/2023, NDC 63629-1088-01) was distributed to one wholesaler in Alabama for further distribution in the United States.
Patients and healthcare providers who have received this medication should verify the actual tablet strength and contact their healthcare provider or pharmacist to ensure they have the correct strength for their prescription.
The recalled product
- Product
- Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01.
- Manufacturer
- Bryant Ranch Prepack, Inc.
- Category
- Drug — Opioid - Extended Release
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 179642
- Exp. Date 11/30/2023.
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 2 recalled by Bryant Ranch Prepack, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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