Prednisolone recalls

The FDA has published 6 recalls involving Prednisolone since 2017. The latest was reported on 8 Jul 2026. Most were for potency & assay. Akorn has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2017

Last 12 months2reported

Class I00% of total

Ongoing4latest 8 Jul 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 1 1Jul 0 0

Severity split

Class I 0 0%Class II 4 67%Class III 2 33%

Why prednisolone is recalled

Companies

Akorn233%
Teva Pharmaceuticals U117%
Mckesson Medical-Surgical Inc. Corporate Office117%
AbbVie117%
Lupin Pharmaceuticals117%

Brands

Prednisolone Acetate233%
Pred Mild117%

By year

2026233%
2023117%
2022233%
2017117%

Ongoing prednisolone recalls

4 active

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate	Lupin Pharmaceuticals	Sterility	Nationwide
3 Jun 2026Drug	CLASS III	Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild	AbbVie	Labeling Errors	Nationwide
7 Jun 2023Drug	CLASS II	Prednisolone Oral Solution, USP, 15 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide
24 Aug 2022Drug	CLASS II	PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn	Akorn	Packaging Defects	Nationwide

All prednisolone recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	prednisoLONE Acetate Ophthalmic Suspension recalledPrednisolone Acetate	Lupin Pharmaceuticals	Sterility	Nationwide
3 Jun 2026Drug	CLASS III	Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbViePred Mild	AbbVie	Labeling Errors	Nationwide
7 Jun 2023Drug	CLASS II	Prednisolone Oral Solution, USP, 15 mg recalled by Akorn	Akorn	Potency & Assay	Nationwide
24 Aug 2022Drug	CLASS II	PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn	Akorn	Packaging Defects	Nationwide
15 Jun 2022Drug	CLASS II	Prednisolone Acetate Ophthalmic Suspension recalledPrednisolone Acetate	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
17 May 2017Drug	CLASS III	PrednisoLONE Oral Solution USP, 15 mg/, alcohol content: 5%(v/v) recalled	Teva Pharmaceuticals U	Potency & Assay	Nationwide

Should you stop taking Prednisolone?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.