CLASS II Drug recall · Reported 17 Aug 2022 · FDA Enforcement Report
Miralax (Polyethylene Glycol 3350), Powder for Solution recalled
Mckesson Medical-Surgical Inc. Corporate Office is recalling Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily, distributed nationwide in the US. The recall was initiated on 29 Jun 2022 and the FDA has classified it as Class II.
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-1319-2022
- FDA event ID
- 90553
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA
- Brand
- Miralax
- Manufacturer
- Bayer HealthCare LLC.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2022
- FDA classified
- 5 Aug 2022
- Reported
- 17 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 29 Jun 2022 | Recall initiated by company | |
| 5 Aug 2022 | Classified by FDA | +37 days |
| 17 Aug 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
CGMP Deviations: products were stored outside the drug label specifications.
Product as listed by the FDA
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Healthcare Pharmaceuticals, NDC 11523-7234-4.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
CGMP Deviations: products were stored outside the drug label specifications.
Which lots are affected?
Part# 11523723404
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
16 other products · FDA event 90553This product is part of a recall event; the main page for the event is Systane Zaditor, ketotifen fumarate ophthalmic solution recalled.
More recalls from Mckesson Medical-Surgical Inc. Corporate Office
All 276| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Clearview Strep A Exact II Dipstick Respiratory Kit, CLIA Waived recalled | Mckesson Medical-Surgical Inc. Corporate Office | Other | Nationwide |
| Drug | CLASS II | Prolia (denosumab), injection, 60mg/mL, For Subcutaneous Use Only recalledProlia | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Benlysta (belimumab) for injection, 400 mg/ vial recalledBenlysta | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Drug | CLASS II | Evenity, (romosozumab -aqqg) injection, 105mg recalledEvenity | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | FL, VA |
| Device | CLASS II | Abbott Diagnostics Alinity I Anti-ccps Reagent recalled | Mckesson Medical-Surgical Inc. Corporate Office | Device Malfunction | Nationwide |
Other Polyethylene Glycol 3350 recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | GaviLyte -C (Polyethylene Glycol 3350 and electrolytes recalledGavilyte - C | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | GaviLyteTM - C PEG-3350 and Electrolytes for Oral Solution recalledGavilyte - C | Novel Laboratories Inc. d.b.a Lupin | Potency & Assay | Nationwide |
| Drug | CLASS II | Polyethylene Glycol 3350 Powder recalled by Cardinal HealthPolyethylene Glycol 3350 | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Polyethylene Glycol 3350 Powder for Solution, Laxative recalledPolyethylene Glycol 3350 | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Gavilyte-N, PEG-3350, Sodium chloride recalled by Lupin SomersetGavilyte-n | Lupin Somerset | Other | Nationwide |