Miralax — Class II drug recall D-1319-2022
Terminated recall by Mckesson Medical-Surgical Inc. Corporate Office, reported 2022-08-17, distributed nationwide. CGMP Deviations: products were stored outside the drug label specifications.
| Recall number | D-1319-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mckesson Medical-Surgical Inc. Corporate Office, Richmond, VA, United States |
| Recall initiated | 2022-06-29 |
| Classified | 2022-08-05 |
| Reported by FDA | 2022-08-17 |
| Terminated | 2024-02-13 |
| Distributed | Nationwide (US) |
| Quantity | 67 bottles |
| Reason classes | labeling, cgmp |
| NDC | 11523-4357, 11523-4357-01, 11523-4357-02, 11523-4357-03, 11523-4357-05, 11523-7234, 11523-7234-01, 11523-7234-02, 11523-7234-03, 11523-7234-04, 11523-7234-05, 11523-7234-06, 11523-7234-09, 11523-7268, 11523-7268-03, 11523-7268-04, 11523-7268-05, 11523-7268-07, 11523-7268-08, 11523-7268-09, 11523-7341, 11523-7341-01, 11523-7341-02 |
| Model numbers | 11523723404 |
Product
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.
Reason for recall
CGMP Deviations: products were stored outside the drug label specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1319-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.