Graviti Pharmaceuticals Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence
Graviti Pharmaceuticals is recalling 29,056 bottles of 10 mg Atorvastatin Calcium Tablets because a 20 mg tablet was found in a bottle labeled for 10 mg tablets.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation where use of, or exposure to, the product may cause temporary or medically reversible health consequences. The hazard is a potential dosing error due to a foreign tablet, which is a moderate risk.
Plain-English summary
Graviti Pharmaceuticals Private Limited is recalling 29,056 bottles of Atorvastatin Calcium Tablets, USP, 10 mg, 90-count. The recall is due to a customer complaint reporting the presence of a foreign 20 mg Atorvastatin Calcium Tablet in a bottle labeled as containing 10 mg tablets.
The affected product is identified by Lot # ATA318099C with an expiration date of 12/2020. The product was distributed nationwide in the USA. The tablets are manufactured for Biocon Pharma Inc. and manufactured by Graviti Pharmaceuticals Private Limited.
Consumers should check their medication for this specific lot number and expiration date. If the product matches the description, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
- Manufacturer
- Graviti Pharmaceuticals Private Limited
- Category
- Drug — Prescription Medication
- Affected units
- 29,056
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 #: ATA318099C
- Exp 12/2020
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Graviti Pharmaceuticals Private Limited
See all →- HighFurosemide tablets recalled over the presence of a foreign substance
FDA (Drugs) · 2026-01-28
- ModerateBupropion extended release tablets recalled after failing tablet specifications
FDA (Drugs) · 2025-10-29
Same hazard · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateApotex Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2019-11-06
- ModerateRanbaxy Recalls Atorvastatin Calcium Tablets Due to Foreign Tablet Presence
FDA (Drugs) · 2014-03-05
- HighSun Pharmaceutical Recalls Atorvastatin Calcium Tablets Due to Foreign Matter
FDA (Drugs) · 2020-03-25
- ModerateDr. Reddy's Recalls Atorvastatin Calcium Tablets Due to Foreign Object
FDA (Drugs) · 2018-06-27
- HighRanbaxy Recalls Atorvastatin Calcium Tablets Due to Glass Particulates
FDA (Drugs) · 2012-12-05
- HighFurosemide tablets recalled over the presence of a foreign substance
FDA (Drugs) · 2026-01-28