CLASS II Drug recall · Reported 2 Feb 2022 · FDA Enforcement Report
Pioglitazone Tablets USP, 45 mg recalled by Aurobindo Pharma USA
Aurobindo Pharma USA is recalling Pioglitazone Tablets USP, 45 mg, distributed nationwide in the US. The recall was initiated on 29 Dec 2021 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-0450-2022
- FDA event ID
- 89323
- Recalling firm
- Aurobindo Pharma USA, East Windsor, NJ
- Brand
- Pioglitazone
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Dec 2021
- FDA classified
- 24 Jan 2022
- Reported
- 2 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 29 Dec 2021 | Recall initiated by company | |
| 24 Jan 2022 | Classified by FDA | +26 days |
| 2 Feb 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent and Failed Tablet/Capsule Specifications
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
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
Where it was distributed
Nationwide in the US
Questions about this recall
Why was it recalled?
Superpotent and Failed Tablet/Capsule Specifications
Which lots are affected?
Batch # PF4520028B & PF4520028A, Exp. Date 11/2022
Where was it sold?
Nationwide in the US
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 Aurobindo Pharma USA
All 59| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Dicyclomine Hydrochloride Capsules, USP, 10mg recalledDicyclomine Hydrochloride | Aurobindo Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nebivolol Tablets recalled by Aurobindo Pharma USANebivolol | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 90 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Cinacalcet Tablets, 30 mg recalled by Aurobindo Pharma USA | Aurobindo Pharma USA | Nitrosamine Impurity | Nationwide |
Other Pioglitazone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg recalled | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Pioglitazone Hydrochloride Tablets USP 15 mg recalledPioglitazone | Macleods Pharma Usa | Potency & Assay | NJ |
| Drug | CLASS II | Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS II | Pioglitazone, Tablet, 15 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Pioglitazone HCL, Tablet, 15 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |