Atorvastatin Calcium 80 mg tablets recalled for manufacturing quality deviations
Accord Healthcare recalls Atorvastatin Calcium 80 mg tablets due to manufacturing process deviations identified during FDA inspection. 72,376 bottles were distributed in the US, Puerto Rico, and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall for manufacturing quality deviations without any reported illnesses or injuries. The recall represents a risk-of-harm situation due to manufacturing process failures, but the absence of reported adverse events places this at the High level rather than Severe.
Plain-English summary
Accord Healthcare, Inc. is recalling Atorvastatin Calcium Tablets USP 80 mg due to Current Good Manufacturing Practice (CGMP) deviations identified during an FDA inspection. The recalled product includes tablets packaged as 90-tablet bottles (NDC 16729-047-15) and 500-tablet bottles (NDC 16729-047-16).
Current Good Manufacturing Practice (CGMP) standards regulate the processes and quality controls used in pharmaceutical manufacturing. The FDA identified deviations from these standards during an inspection.
72,376 bottles were distributed across the United States, including Puerto Rico and Canada. The affected batches include R2100283, R2100288, R2100289, R2200235, R2201037, R2200952, and others, with expiration dates ranging from February 2023 to June 2024.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Accord Healthcare, Inc.
- Category
- Drug — Prescription Medication
- Hazard
- cgmp-deviation
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 (20)
- Batches: a)R2100283
- R2100288
- R2100289
- Exp. Date 2/28/2023
- R2200235
- Exp. Date 1/31/2024
- R2201037
- R2200952
- Exp. Date 6/30/2024
- b) R2100291
- R2100281
- R2100282
- R2100292
- R2100293
- R2100294
- R2100290
- R2100306
- R2100348
- R2100349
- R2100347
UPCs (2)
- 316729047159
- 316729047166
Distribution
Distribution scope not specified by the agency.
Related recalls
Same brand · ATORVASTATIN CALCIUM
- HighBiocon Pharma atorvastatin calcium tablets recalled for failed dissolution specifications
FDA (Drugs) · 2025-04-09
- HighPrescription atorvastatin bottles recalled for containing wrong medication
FDA (Drugs) · 2024-10-09
- ModerateAtorvastatin Calcium Tablets Recalled for Manufacturing Quality Violations
FDA (Drugs) · 2023-05-03
- ModeratePrescription Drug Recall: Atorvastatin Calcium Tablets for Manufacturing Deviations
FDA (Drugs) · 2023-03-08
- HighAtorvastatin Calcium tablets recalled due to manufacturing practice deviations
FDA (Drugs) · 2023-03-08
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- SevereAtomoxetine Capsules Recalled Due to Labeling Mix-Up Error
FDA (Drugs) · 2026-05-27
- SevereCIMZIA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- ModerateVitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid
FDA (Drugs) · 2026-05-27