CLASS III Drug recall · Reported 14 Aug 2024 · FDA Enforcement Report
Methotrexate Tablets, USP, 2.5mg recalled by Amneal Pharmaceuticals
Amneal Pharmaceuticals is recalling Methotrexate Tablets, USP, 2.5mg, distributed nationwide in the US. The recall was initiated on 1 Aug 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0629-2024
- FDA event ID
- 95082
- Recalling firm
- Amneal Pharmaceuticals, Bridgewater, NJ
- Classification
- Class III
- Status
- Completed
- Recall initiated
- 1 Aug 2024
- FDA classified
- 8 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Cancer Medication
Timeline
| 1 Aug 2024 | Recall initiated by company | |
| 8 Aug 2024 | Classified by FDA | +7 days |
| 14 Aug 2024 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Product as listed by the FDA
Methotrexate Tablets, USP, 2.5mg, 100-count Bottle, RX Only, Distributed By: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807, NDC# 69238-1423-1
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets: Potential presence of Fludrocortisone Acetate Tablet USP 0.1 mg within the Methotrexate 2.5 mg 100-count Bottle.
Which lots are affected?
Lot # BB29124, Exp. 02/28/2026
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amneal Pharmaceuticals
All 25| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg, 30-packets recalledEstradiol | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone | Amneal Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Magnesium Sulfate in Water for Injection (40mg/mL) IV recalledMagnesium Sulfate | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
| Drug | CLASS II | traMADol Hydrochloride Tablets, USP, 50 mg recalled | Amneal Pharmaceuticals | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | chlorproMAZINE Hydrochloride Tablets, USP, 50 mg recalledChlorpromazine Hydrochloride | Amneal Pharmaceuticals | Packaging Defects | Nationwide |
Other Methotrexate recalls
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Methotrexate Tablets, USP, 2.5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS II | Methotrexate, USP, Sterile Solution for Injection (PF) recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Methotrexate Injection, USP 50 mg recalled by Cardinal HealthMethotrexate | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Methotrexate, USP Sterile Solution for Injection recalled by Edge Pharma | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Methotrexate 25 MG / Im Syr recalled by Infusion Options | Infusion Options | Sterility | NY |