CLASS I Drug recall · Reported 27 Jun 2012 · FDA Enforcement Report

Morphine Sulfate Immediate Release tablet, 30 mg recalled

Physicians Total Care is recalling Morphine Sulfate Immediate Release tablet, 30 mg, distributed in Florida. The recall was initiated on 10 Nov 2010 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesPTC Drug Number: 4973. PTC Batch Number: 65J2. Batch Date: 10/13/2010. Expiration Date: 06/30/2012. NDC: 54868-4973-00

Quantity recalled600 tablets (5 containers of 120 tablets each)

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-1386-2012
FDA event ID: 61233
Recalling firm: Physicians Total Care, Tulsa, OK
Classification: Class I
Status: Terminated
Recall initiated: 10 Nov 2010
FDA classified: 18 Jun 2012
Reported: 27 Jun 2012
Type: Voluntary: Firm initiated
Customers notified by: FAX
Reason category: Packaging Defects
Drug class: Pain Medication

Timeline

10 Nov 2010	Recall initiated by company
18 Jun 2012	Classified by FDA	+586 days
27 Jun 2012	Published in enforcement report	+9 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 to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.

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 Immediate Release tablet, 30 mg/120 tablet bottles, Rx only, Physician Total Care, Inc, Tulsa, OK 74146-6234, NDC 54868-4973-00

Where it was distributed

Florida

Questions about this recall

Why was it recalled?

Labeling: Label mix-up; Bottles labeled to contain Morphine Sulfate IR may contain Morphine Sulfate ER and vice-versa.

Which lots are affected?

PTC Drug Number: 4973. PTC Batch Number: 65J2. Batch Date: 10/13/2010. Expiration Date: 06/30/2012. NDC: 54868-4973-00

Where was it sold?

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 61233

This product is part of a recall event; the main page for the event is Morphine Sulfate Extended Release tablet, 30 mg recalled.

Reported	Class	Recall	Company	Reason	Where
27 Jun 2012	CLASS I	Morphine Sulfate Extended Release tablet, 30 mg recalled	Physicians Total Care	Packaging Defects	FL

More recalls from Physicians Total Care

All 21

Reported	Class	Recall	Company	Reason	Where
12 Nov 2014Drug	CLASS II	Cephalexin Monohydrate Capsules,USP, 500 mg recalled	Physicians Total Care	Manufacturing (CGMP) Deviations	GA, MO
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7 Aug 2013Drug	CLASS II	Belladonna Alkaloids/PB (Belladonna Alkaloids recalled	Physicians Total Care	Packaging Defects	GA
12 Jun 2013Drug	CLASS III	Voltaren 1% Gel, 100 gm tube recalled by Physicians Total Care	Physicians Total Care	Other	Nationwide

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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