CLASS II Drug recall · Reported 2 May 2018 · FDA Enforcement Report

Morphine Sulfate 2 mg/mL PF Injection recalled by Premier Pharmacy Labs

Premier Pharmacy Labs is recalling Morphine Sulfate 2 mg/mL PF Injection, distributed nationwide in the US. The recall was initiated on 11 Apr 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLots: MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, MOR030518IJDSE BUD: 06/03/2018;

Quantity recalled4555 syringes

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-0699-2018
FDA event ID: 79803
Recalling firm: Premier Pharmacy Labs, Weeki Wachee, FL
Classification: Class II
Status: Terminated
Recall initiated: 11 Apr 2018
FDA classified: 26 Apr 2018
Reported: 2 May 2018
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Pain Medication

Timeline

11 Apr 2018	Recall initiated by company
26 Apr 2018	Classified by FDA	+15 days
2 May 2018	Published in enforcement report	+6 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 Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.

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 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

Lots: MOR030518IJDSA, MOR030518IJDSB, MOR030518IJDSC, MOR030518IJDSD, MOR030518IJDSE BUD: 06/03/2018;

Where was it sold?

Nationwide in the USA

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

3 other products · FDA event 79803

This product is part of a recall event; the main page for the event is NEOstigmine Methylsulfate (1 mg/mL) 3mg per Single Dose Syringe recalled.

Reported	Class	Recall	Company	Reason	Where
2 May 2018	CLASS II	NEOstigmine Methylsulfate (1 mg/mL) 3mg per Single Dose Syringe recalled	Premier Pharmacy Labs	Sterility	Nationwide
2 May 2018	CLASS II	Morphine Sulfate 4 mg/mL PF Injection recalled by Premier Pharmacy Labs	Premier Pharmacy Labs	Sterility	Nationwide
2 May 2018	CLASS II	Hydromorphone HCl 1 mg/mL PF INJ recalled by Premier Pharmacy Labs	Premier Pharmacy Labs	Sterility	Nationwide

More recalls from Premier Pharmacy Labs

All 24

Reported	Class	Recall	Company	Reason	Where
3 Jul 2019Drug	CLASS II	Naloxone HCL Preserved INJ, 500mg/ (10mg/mL) Sterile MDV recalled	Premier Pharmacy Labs	Sterility	Nationwide
3 Jul 2019Drug	CLASS II	Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg recalled	Premier Pharmacy Labs	Sterility	Nationwide
3 Jul 2019Drug	CLASS II	Orphenadrine Citrate Sterile Injectable Solution *Contains recalled	Premier Pharmacy Labs	Sterility	Nationwide
3 Jul 2019Drug	CLASS II	Mitomycin Preservative Free Irrigation, 40mg/ (4mg/mL) SDV recalled	Premier Pharmacy Labs	Sterility	Nationwide
3 Jul 2019Drug	CLASS II	Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg recalled	Premier Pharmacy Labs	Sterility	Nationwide

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