Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.
0 Class I (most serious) drug recalls reported in the last 30 days.
5 recalls
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Class II Ongoing
methylprednisolone tablets, USP Dosepak, 4 mg, 1 Blister Card per Carton containing 21 Tablets, Rx only, Distributed by: Greenstone LLC, Peapack, NJ 07977. NDC 59762-4440-2
Reason: Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Lots, distribution and details
- Lots / codes
- Lot # LG7675, Exp. Date Nov 2026
- Distribution
- Nationwide within the United States
- Quantity
- 3456 cartons
- Recall started
- January 15, 2026 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0299-2026
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Class II Ongoing
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
Reason: Presence of Particulate Matter: Potential for black particulates in the drug product.
Lots, distribution and details
- Product
- MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
- Lots / codes
- Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
- Distribution
- Nationwide in the USA
- Quantity
- 14,360 vials
- Recall started
- April 25, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0499-2024
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Class II Ongoing
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Reason: Failed Dissolution Specifications
Lots, distribution and details
- Lots / codes
- Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
- Distribution
- OH, TN, LA, MS
- Quantity
- 10,080 vials
- Recall started
- February 20, 2024 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-0366-2024
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Class III Ongoing
Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubila…
Reason: Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed dosing instructions on the blister card.
Lots, distribution and details
- Product
- Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, DocRx, Mobile, AL 36608
- Lots / codes
- Lot #: 20K0043P, Exp. 8/31/2022; 20L0026P, Exp. 9/30/2022
- Distribution
- Distributed to three physicians in the following states: CA, LA (Enovachem). DocRx distributed recalled product to one Distributor located in AL.
- Quantity
- N/A
- Recall started
- March 19, 2021 (Voluntary: Firm initiated)
- Severity
- Not likely to cause health problems — for example a labelling or packaging fault.
- FDA recall number
- D-0330-2021
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Class II Ongoing
Methylprednisolone Acetate 80 mg/ml Injection, compounded by Olympia, FL
Reason: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Lots, distribution and details
- Lots / codes
- A3104 Exp 6/4/13
- Distribution
- Nationwide and PR
- Quantity
- 1
- Recall started
- May 29, 2013 (Voluntary: Firm initiated)
- Severity
- Could cause temporary or medically reversible health problems; serious harm is unlikely.
- FDA recall number
- D-758-2013
Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.
What the recall classes mean
- Class I Most serious: use could cause serious health problems or death.
- Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
- Class III Not likely to cause health problems — for example a labelling or packaging fault.
Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.