Sun Pharmaceutical Recalls Atorvastatin Calcium Tablets Due to Foreign Matter
Sun Pharmaceutical Industries is recalling 1,416 bottles of Atorvastatin Calcium 40 mg tablets because a latex glove was found in one lot.
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: The recall involves a risk-of-harm product (foreign matter in medication) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Sun Pharmaceutical Industries, Inc. is recalling 1,416 bottles of Atorvastatin Calcium Tablets, USP 40 mg, 500-count bottles. The recall affects Lot #AA33617 with an expiration date of 03/2021. The product is distributed nationwide in the U.S.A.
The recall was initiated because foreign matter, specifically a latex glove, was identified in one lot of the tablets. The product is a prescription-only medication manufactured by Sun Pharmaceutical Industries Limited in Mohali, India, and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, NJ.
Consumers who have this specific lot of Atorvastatin Calcium tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- ATORVASTATIN CALCIUM (ATORVASTATIN CALCIUM)
- Brand
- ATORVASTATIN CALCIUM
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 1,416
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)
- Lot#: AA33617
- Exp 03/2021
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ATORVASTATIN CALCIUM
- ModerateAtorvastatin 40 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- ModerateAtorvastatin 10 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- ModerateAtorvastatin 80 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- ModerateAtorvastatin 20 mg tablets recalled after failing dissolution specifications
FDA (Drugs) · 2025-10-22
- HighBiocon Pharma atorvastatin calcium tablets recalled for failed dissolution specifications
FDA (Drugs) · 2025-04-09
Same manufacturer · Sun Pharmaceutical Industries, Inc.
See all →- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- LowFexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08
- HighPerampanel Prescription Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-07-01
- HighBudesonide inhalation ampules contain black and brown specks and particles
FDA (Drugs) · 2026-06-17
- SevereDoxorubicin liposome injection vials contain glass particulate matter
FDA (Drugs) · 2026-06-17
Same hazard · foreign matter
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighLidocaine Injection Recall Due to Hair Contamination
FDA (Drugs) · 2026-07-29
- ModerateDivalproex Sodium Delayed-Release Tablets Recalled Due to Presence of Foreign Tablets
FDA (Drugs) · 2026-07-29
- ModeratePasteurized donor human milk bottles show dark spot contamination
FDA (Food) · 2026-06-17
- ModerateVitamin B-Complex and Vitamin C Dietary Supplement Recalled for Foreign Matter
FDA (Food) · 2026-05-27