Pioglitazone Tablets Recalled for Superpotent and Failed Specifications
Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone 45 mg tablets distributed nationwide due to superpotent tablets and tablets that fail to meet specifications.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall involving a prescription drug with manufacturing defects (superpotency and failed specifications) that could affect drug efficacy and patient safety. Class II recalls with potential health consequences warrant a Severe classification.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Pioglitazone Tablets USP, 45 mg (500 count bottles) distributed nationwide in the United States. The recall affects NDC 57237-221-05 with batch numbers PF4520028B and PF4520028A, expiring 11/2022. A total of 792 bottles are affected by this recall.
The tablets are being recalled because they are superpotent and fail to meet tablet specifications. This means some tablets contain higher amounts of the active ingredient than intended, and some tablets do not meet required manufacturing standards.
Patients taking this medication should consult their healthcare provider or pharmacist before taking further doses. Those who have dispensed this product should notify their customers and quarantine all affected stock. Healthcare providers and patients should report any adverse events to the FDA's MedWatch program.
The recalled product
- Product
- PIOGLITAZONE (PIOGLITAZONE)
- Brand
- PIOGLITAZONE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 792
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch # PF4520028B & PF4520028A
- Exp. Date 11/2022
UPCs (3)
- 0357237221303
- 0357237220306
- 0357237219300
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PIOGLITAZONE
- HighMacleods Pharma Recalls Pioglitazone Tablets Due to Superpotent Content
FDA (Drugs) · 2019-10-23
Same manufacturer · Aurobindo Pharma USA Inc.
See all →- ModerateDicyclomine Hydrochloride Capsules Recalled for Empty Capsules
FDA (Drugs) · 2026-08-12
- ModerateAmazon Basic Care Acetaminophen 325 mg Tablets Recalled Due to Discoloration
FDA (Drugs) · 2025-06-25
- HighPrescription drug recall: Aurobindo Nebivolol tablets contain excess nitrosamine impurity
FDA (Drugs) · 2024-12-25
- HighPrescription Cinacalcet Tablets Recalled for N-Nitroso Impurity
FDA (Drugs) · 2024-12-11
- HighCinacalcet Tablets Recalled for N-Nitroso Impurity Exceeding FDA Safety Limit
FDA (Drugs) · 2024-12-11
Same hazard · superpotency
See all →- CriticalVitruvias Recalls Superpotent Thyroid Tablets Nationwide
FDA (Drugs) · 2026-09-23
- HighAripiprazole 10 mg tablets recalled after testing superpotent in one lot
FDA (Drugs) · 2025-09-24
- ModerateHYDROmorphone Hydrochloride 50 mg Cassettes Recalled for Superpotency
FDA (Drugs) · 2025-04-30
- HighLevothyroxine Sodium Tablets Recalled Nationwide for Potency Variance
FDA (Drugs) · 2024-12-18
- HighLevothyroxine Sodium Tablets Recalled for Subpotent and Superpotent Content
FDA (Drugs) · 2024-12-18
Similar recalls
- HighMacleods Pharma Recalls Pioglitazone Tablets Due to Superpotent Content
FDA (Drugs) · 2019-10-23
- ModerateMacleods Pharma Recalls Subpotent Pioglitazone and Metformin Tablets
FDA (Drugs) · 2020-02-12
- LowAurobindo Recalls Simvastatin Tablets Due to Incorrect Lot and Expiration Dates
FDA (Drugs) · 2019-09-04
- SevereAurobindo Recalls Famotidine 40mg Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2021-03-10
- ModerateAurobindo Recalls Mirtazapine Tablets Due to Manufacturing Water Leakage
FDA (Drugs) · 2020-04-22
- SevereAuroMedics Recalls Mirtazapine Tablets Due to Labeling Error
FDA (Drugs) · 2019-12-18