CLASS II Drug recall · Reported 1 Feb 2023 · FDA Enforcement Report
Allopurinol Tablets USP, 100 mg recalled by Accord Healthcare
Accord Healthcare is recalling Allopurinol Tablets USP, 100 mg, distributed nationwide in the US. The recall was initiated on 12 Jan 2023 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-0168-2023
- FDA event ID
- 91499
- Recalling firm
- Accord Healthcare, Durham, NC
- Brand
- Allopurinol
- Manufacturer
- Accord Healthcare Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Jan 2023
- FDA classified
- 20 Jan 2023
- Reported
- 1 Feb 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
Timeline
| 12 Jan 2023 | Recall initiated by company | |
| 20 Jan 2023 | Classified by FDA | +8 days |
| 1 Feb 2023 | Published in enforcement report | +12 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 Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Which lots are affected?
Lots: R2200455, R2200456 Exp. 03/2025
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 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 Accord Healthcare
All 106| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg) recalledLevothyroxine Sodium | Accord Healthcare | Potency & Assay | Nationwide |
| Drug | CLASS II | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg) recalledLevothyroxine Sodium | Accord Healthcare | 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 | Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial recalledAloprim | Mylan Institutional | Potency & Assay | Nationwide |
| Drug | CLASS III | Allopurinol Tablets, USP, 300 mg recalled by Qualitest PharmaceuticalsAllopurinol | Qualitest Pharmaceuticals | Other | Nationwide |