AvKARE

Complete recall history across all FDA and CPSC categories — 20 total recalls

AvKARE appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (20)

FDA drug safety enforcement actions by AvKARE

Date Product Reason Class
Feb 13, 2026 Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Onl... Failed Dissolution Specifications: This recall has been initiated due to an O... Class II
Dec 31, 2025 Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per ... Out of specification for dissolution. Class II
Sep 2, 2025 Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0... Failed Content Uniformity Specifications Class II
Aug 25, 2025 chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit do... Presence of a foreign substance. Class II
Aug 25, 2025 chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dos... Presence of a foreign substance. Class II
Jun 26, 2025 Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III
Jun 26, 2025 Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... Failed Impurity/Degradation Specifications Class III
May 13, 2025 Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only,... Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadal... Class II
May 9, 2025 Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per car... Failed Dissolution Specifications Class II
Feb 4, 2025 Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, ... Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.65... Class II
Jan 21, 2025 Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Man... Out of Specification for Dissolution Class II
Dec 18, 2024 Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops,... LABELING: LABEL MIX-UP Class III
Dec 18, 2024 Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant... LABELING: LABEL MIX-UP Class III
Dec 4, 2024 Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per cart... Failed Dissolution Specifications Class II
Nov 27, 2024 Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDS... Class II
Nov 27, 2024 Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDS... Class II
Nov 27, 2024 Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE... CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDS... Class II
Oct 18, 2024 Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for... Labeling: Label Mix-Up Class II
Oct 18, 2024 Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured f... Labeling: Label Mix-Up Class II
Mar 28, 2024 Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... Microbial contamination of a non-sterile product: potential Bacillus cereus c... Class I

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

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