CLASS II Drug recall · Reported 15 Aug 2018 · FDA Enforcement Report

Morphine Sulfate 1 mg/mL CADD recalled by Guardian Pharmacy Services

Guardian Pharmacy Services is recalling Morphine Sulfate 1 mg/mL CADD, distributed in Texas. The recall was initiated on 17 May 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: 58440:42 Use By: 05/23/2018; 58624:42 Use By: 06/11/2018; 58962:42 Use By: 07/11/2018

Quantity recalled20 25-ml CADD

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-1051-2018
FDA event ID: 80118
Recalling firm: Guardian Pharmacy Services, Dallas, TX
Classification: Class II
Status: Terminated
Recall initiated: 17 May 2018
FDA classified: 8 Aug 2018
Reported: 15 Aug 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Pain Medication

Timeline

17 May 2018	Recall initiated by company
8 Aug 2018	Classified by FDA	+83 days
15 Aug 2018	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of sterility assurance.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

Where it was distributed

Texas

Questions about this recall

Why was it recalled?

Lack of sterility assurance.

Which lots are affected?

Lots: 58440:42 Use By: 05/23/2018; 58624:42 Use By: 06/11/2018; 58962:42 Use By: 07/11/2018

Where was it sold?

Texas

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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

22 other products · FDA event 80118

This product is part of a recall event; the main page for the event is Methylene Blue 10 mg/mL recalled by Guardian Pharmacy Services.

Reported	Class	Recall	Company	Reason	Where
15 Aug 2018	CLASS II	Methylene Blue 10 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Glutathione 200 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Ascorbic Acid 500 mg/mL vial recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Hyaluronidase/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Glutathione 200 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Ascorbic Acid 500 mg/mL TPN recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Glutathione 200 mg/mL MDV recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Phenol 6% with Glycerin Inj recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Mic "b" Combo Lipotropic recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Cefazolin 2 Gm recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Glycopyrrolate 0.2 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Ropivacaine HCl 2 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. recalled	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Ropivacaine HCl 2 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Ropivacaine HCl 2 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Medroxyprogesterone 150 mg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Fentanyl Citrate 50 mcg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Methylcobalamin 1000 mcg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Hyaluronidase/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Magnesium Sulfate 200 mg/mL Rx. Only recalled	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	EDTA Disodium 30 mg/mL PF recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018	CLASS II	Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded recalled	Guardian Pharmacy Services	Sterility	TX

More recalls from Guardian Pharmacy Services

All 24

Reported	Class	Recall	Company	Reason	Where
15 Aug 2018Drug	CLASS II	Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded recalled	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	EDTA Disodium 30 mg/mL PF recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	Magnesium Sulfate 200 mg/mL Rx. Only recalled	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	Hyaluronidase/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX
15 Aug 2018Drug	CLASS II	Methylcobalamin 1000 mcg/mL recalled by Guardian Pharmacy Services	Guardian Pharmacy Services	Sterility	TX

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