CLASS II Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
Pyrazinamide Tablets, USP 500 mg recalled by ANI Pharmaceuticals
ANI Pharmaceuticals is recalling Pyrazinamide Tablets, USP 500 mg, distributed nationwide in the US. The recall was initiated on 15 Feb 2022 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-0568-2022
- FDA event ID
- 89556
- Recalling firm
- ANI Pharmaceuticals, Baudette, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2022
- FDA classified
- 17 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 15 Feb 2022 | Recall initiated by company | |
| 17 Feb 2022 | Classified by FDA | +2 days |
| 23 Feb 2022 | 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
cGMP Deviations
Product as listed by the FDA
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot #: 19B064A, Exp. Date 03/2022
Where was it sold?
Nationwide within the United States
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.
Other products in this recall event
4 other products · FDA event 89556This product is part of a recall event; the main page for the event is Alprazolam Tablets, USP 0.5 mg recalled by ANI Pharmaceuticals.
More recalls from ANI Pharmaceuticals
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg per packet, 30 packets recalledEstradiol | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP 1.0 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP 2.0 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP 0.25 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Pyrazinamide recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card recalled | RemedyRepack | Manufacturing (CGMP) Deviations | PA |