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

Lot, batch or date codesLot #: 179643, Exp. Date 08/31/2023.

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-1188-2022
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; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01

Where it was distributed

Distributed to one wholesaler in AL for further distribution in the US.

Alabama

Questions about this recall

Why was it recalled?

Which lots are affected?

Lot #: 179643, Exp. Date 08/31/2023.

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 90481

Reported	Class	Recall	Company	Reason	Where
20 Jul 2022	CLASS I	Morphine Sulfate extended-Release Tablets recalled	Bryant Ranch Prepack	Packaging Defects	AL

More recalls from Bryant Ranch Prepack

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12 Jun 2024Drug	CLASS III	Cephalexin for Oral Suspension, USP, 125mg recalledCephalexin	Bryant Ranch Prepack	Other	Nationwide
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Other Morphine recalls

All 147

Reported	Class	Recall	Company	Reason	Where
26 Aug 2026Drug	CLASS I	Morphine Sulfate Injection recalled by Fresenius Kabi USAMorphine Sulfate	Fresenius Kabi USA	Packaging Defects	Nationwide
17 Dec 2025Drug	CLASS III	Morphine Sulfate Oral Solution 100 mg / (20 mg* / mL) recalledMorphine Sulfate	Winder Laboratories	Packaging Defects	Nationwide
12 Mar 2025Drug	CLASS II	Morphine Sulfate Extended-Release Tablets, 100 mg recalledMorphine Sulfate	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
13 Nov 2024Drug	CLASS II	Morphine Sulfate Extended-Release Tablets 30 mg recalled	Dr. Reddy's Laboratories	Potency & Assay	Nationwide
27 Mar 2024Drug	CLASS II	Infumorph (Preservative-free Morphine Sulfate Sterile recalledInfumorph 200	Hikma Pharmaceuticals USA	Other	Nationwide