CLASS I Drug recall · Reported 20 Jul 2022 · FDA Enforcement Report
Morphine Sulfate extended-Release Tablets recalled
Bryant Ranch Prepack is recalling Morphine Sulfate extended-Release Tablets, USP, distributed in Alabama. The recall was initiated on 17 Jun 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1187-2022
- FDA event ID
- 90481
- Recalling firm
- Bryant Ranch Prepack, Burbank, CA
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 17 Jun 2022
- FDA classified
- 8 Jul 2022
- Reported
- 20 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 17 Jun 2022 | Recall initiated by company | |
| 8 Jul 2022 | Classified by FDA | +21 days |
| 20 Jul 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets 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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Distributed to one wholesaler in AL for further distribution in the US.
Questions about this recall
Is Morphine Sulfate extended-Release Tablets, USP recalled?
Yes. Bryant Ranch Prepack recalled Morphine Sulfate extended-Release Tablets, USP on 17 Jun 2022. The recall is Class I and its status is Terminated. Recall number D-1187-2022.
Why was it recalled?
Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets 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.
Which lots are affected?
Lot #: 179642, Exp. Date 11/30/2023.
Where was it sold?
Distributed to one wholesaler in AL for further distribution in the US.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Bryant Ranch Prepack
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 250mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
| Drug | CLASS III | Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin | Bryant Ranch Prepack | Other | Nationwide |
Other Morphine recalls
All 27| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate | Fresenius Kabi USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate | Winder Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate | Sun Pharmaceutical Industries | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 30 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Morphine Sulfate Extended-Release Tablets 15 mg recalled | Dr. Reddy's Laboratories | Potency & Assay | Nationwide |