CLASS II Drug recall · Reported 27 May 2020 · FDA Enforcement Report
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial recalled
Mylan Institutional is recalling Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, distributed nationwide in the US. The recall was initiated on 5 May 2020 and the FDA has classified it as Class II.
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-1271-2020
- FDA event ID
- 85624
- Recalling firm
- Mylan Institutional, Rockford, IL
- Brand
- Aloprim
- Manufacturer
- Mylan Institutional LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 May 2020
- FDA classified
- 20 May 2020
- Reported
- 27 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 5 May 2020 | Recall initiated by company | |
| 20 May 2020 | Classified by FDA | +15 days |
| 27 May 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Why was it recalled?
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Which lots are affected?
Lot #: Lot N1700771, EXP October 2020; Lot N1800127, EXP February 2021
Where was it sold?
Distributed 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Mylan Institutional
All 24| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg) recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 137 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg recalledLevothyroxine Sodium | Mylan Institutional | Potency & Assay | Nationwide |
Other Allopurinol recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Allopurinol Tablets, USP 300mg recalled by Dr. Reddy's LaboratoriesAllopurinol | Dr. Reddy's Laboratories | Other | IL, MS, OH |
| Drug | CLASS II | Allopurinol Tablets recalled by Cardinal HealthcareAllopurinol | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Allopurinol Tablets 100mg recalled by Preferred Pharmaceuticals | Preferred Pharmaceuticals | Foreign Material | IN |
| Drug | CLASS II | Allopurinol Tablets USP, 100 mg recalled by Accord HealthcareAllopurinol | Accord Healthcare | Foreign Material | Nationwide |
| Drug | CLASS III | Allopurinol Tablets, USP, 300 mg recalled by Qualitest PharmaceuticalsAllopurinol | Qualitest Pharmaceuticals | Other | Nationwide |