Class III · Low risk
Methotrexate Tablets
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Is Methotrexate recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Methotrexate (14 total). Check the affected lots below.
Most common reason: Sterility / contamination (6 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Methotrexate. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Methotrexate recalls on record
none so far in 2026; 14 on record, newest first
Class III · Low risk
Methotrexate Tablets
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Class II · Moderate risk
Methotrexate Intravitreal
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk
Methotrexate
Lack of Assurance of Sterility
Class II · Moderate risk
Methotrexate Injection
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Methotrexate
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Class II · Moderate risk
Methotrexate 25 Mg / 1 Ml IM Syr
Lack of Assurance of Sterility
Class I · High risk
Methotrexate Injection
Presence of Particulate Matter
Class II · Moderate risk
Methotrexate USP active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Methotrexate Sodium active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Methotrexate Intraocular 400mcg 0.1cc
Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Class I · High risk
Methotrexate Injection
Presence of Particulate Matter: Found during examination of retention samples.
Class II · Moderate risk
Methotrexate 25mg/mL Injectable
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes.
Class II · Moderate risk
Methotrexate Injection
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.