Prednisolone recalls
The FDA has published 21 recalls involving Prednisolone since 2012. The latest was reported on 8 Jul 2026. Most were for sterility. Promise Pharmacy 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 recalls 21 since 2012
Last 12 months 2 reported
Class I 0 0% of total
Ongoing 4 latest 8 Jul 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%17 81%4 19%
Why prednisolone is recalled
Ongoing prednisolone recalls 4 active
All prednisolone recalls, newest first 21 total Reported Class Recall Company Reason Where 8 Jul 2026 Drug CLASS II prednisoLONE Acetate Ophthalmic Suspension recalled Prednisolone Acetate Lupin Pharmaceuticals Other Nationwide 3 Jun 2026 Drug CLASS III Pred Mild, prednisolone acetate ophthalmic suspension recalled by AbbVie Pred Mild AbbVie Potency & Assay Nationwide 7 Jun 2023 Drug CLASS II Prednisolone Oral Solution, USP, 15 mg recalled by Akorn Akorn Potency & Assay Nationwide 24 Aug 2022 Drug CLASS II PrednisoLONE Oral Solution USP, 15 mg recalled by Akorn Akorn Packaging Defects Nationwide 15 Jun 2022 Drug CLASS II Prednisolone Acetate Ophthalmic Suspension recalled Prednisolone Acetate Mckesson Medical-Surgical Inc. Corporate Office Manufacturing (CGMP) Deviations Nationwide 17 Jun 2020 Drug CLASS III Prednisolone Sodium Phosphate Oral Solution, 5 mg recalled by Akorn Akorn Potency & Assay Nationwide 16 Oct 2019 Drug CLASS II Prednisolone Sodium Phosphate Oral Solution, 15 mg recalled Morton Grove Pharmaceuticals Potency & Assay Nationwide 20 Feb 2019 Drug CLASS II Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% recalled Promise Pharmacy Sterility Nationwide 20 Feb 2019 Drug CLASS II Prednisolone and Moxifloxacin Ophthalmic Solution 1%/0.5% recalled Promise Pharmacy Sterility Nationwide 20 Feb 2019 Drug CLASS II Prednisolone and Gatifloxacin recalled by Promise Pharmacy Promise Pharmacy Sterility Nationwide 20 Feb 2019 Drug CLASS II Prednisolone and Gatifloxacin recalled by Promise Pharmacy Promise Pharmacy Sterility Nationwide 20 Feb 2019 Drug CLASS II Prednisolone and Bromfenac Ophthalmic Solution, 1%/0.09% Combo Drops recalled Promise Pharmacy Sterility Nationwide 20 Feb 2019 Drug CLASS II Prednisolone and Gatifloxacin and Bromfenac recalled by Promise Pharmacy Promise Pharmacy Sterility Nationwide 31 Oct 2018 Drug CLASS III Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5% dropper recalled Promise Pharmacy Other Nationwide 15 Aug 2018 Drug CLASS II Prednisolone Sodium Phosphate Oral Solution, 15 mg recalled Morton Grove Pharmaceuticals Packaging Defects Nationwide 17 Jan 2018 Drug CLASS II PrednisoLONE 10 mg Tablet, Rx Only, KRS Global Biotechnology recalled KRS Global Biotechnology Other Nationwide 17 May 2017 Drug CLASS III PrednisoLONE Oral Solution USP, 15 mg/, alcohol content: 5%(v/v) recalled Teva Pharmaceuticals USA Potency & Assay Nationwide 12 Nov 2014 Drug CLASS II Prednisolone Sodium Phosphate, 1%, Ophthalmic, RX recalled Oregon Compounding Centers Sterility OR, WA 5 Nov 2014 Drug CLASS II Prednisolone acetate 50 mg/mL injectable recalled Martin Avenue Pharmacy Sterility Nationwide 22 Jan 2014 Drug CLASS II prednisoLONE, Tablet, 5 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 22 Aug 2012 Drug CLASS II Prednisolone Acetate 10mg/ML Injectable 10 Mls (1 Product) recalled Franck's Lab Inc., d.b.a. Franck's Compounding Lab Sterility 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.