FDA Drug recall D-1319-2022
Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Health…
- FDA Drug
- Class II
- terminated
- Published 2022-08-17
On 2022-08-17 the FDA classified a Class II recall of Miralax (Polyethylene Glycol 3350), Powder for Solution, Osmotic Laxative, 30 Once-Daily Doses, Net WT 17.9 OZ (510 g) bottle, Bayer Health… by Mckesson Medical Surgical Corporate Office, citing CGMP Deviations: products were stored outside the drug label specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1319-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-29 |
| Published | 2022-08-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Mckesson Medical Surgical Corporate Office |
| Distribution | US |
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
CGMP Deviations: products were stored outside the drug label specifications.
Identifiers
| ndc | 11523-7268-3 |
|---|---|
| ndc | 11523-7268-8 |
| ndc | 11523-7268-7 |
| ndc | 11523-7268-4 |
| ndc | 11523-7268-9 |
| ndc | 11523-7268-5 |
| ndc | 11523-7234-1 |
| ndc | 11523-7234-2 |
| ndc | 11523-7234-3 |
| ndc | 11523-7234-4 |
| ndc | 11523-7234-5 |
| ndc | 11523-7234-6 |
| ndc | 11523-7234-9 |
| ndc | 11523-7341-1 |
| ndc | 11523-7341-2 |
| ndc | 11523-4357-1 |
| ndc | 11523-4357-3 |
| ndc | 11523-4357-5 |
| ndc | 11523-4357-2 |
| ndc | 1152372340 |
| code_info | Part# 11523723404 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1319-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.