Records and reported status
Feb 13, 2026 FDA drug enforcement
Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.
Class II Reported ongoing
Distribution: Nationwide in the USA.
Official source for Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for:... Dec 31, 2025 FDA drug enforcement
Out of specification for dissolution.
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured... Sep 2, 2025 FDA drug enforcement
Failed Content Uniformity Specifications
Class II Reported ongoing
Distribution: U.S. Nationwide
Official source for Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg... Aug 25, 2025 FDA drug enforcement
Presence of a foreign substance.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, M... Aug 25, 2025 FDA drug enforcement
Presence of a foreign substance.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, ... Jun 26, 2025 FDA drug enforcement
Failed Impurity/Degradation Specifications
Class III Reported ongoing
Distribution: Nationwide in the USA
Official source for Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN... Jun 26, 2025 FDA drug enforcement
Failed Impurity/Degradation Specifications
Class III Reported ongoing
Distribution: Nationwide in the USA
Official source for Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN... May 13, 2025 FDA drug enforcement
Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: A... May 9, 2025 FDA drug enforcement
Failed Dissolution Specifications
Class II Reported ongoing
Distribution: Nationwide USA
Official source for Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufa... Feb 4, 2025 FDA drug enforcement
Subpotent Drug: Out of Specification (OOS) result for De hydro Impurity (0.654%) for 18 M Stability sample and low assay 94.9% (specification of NLT 95.0% NMT 105%)
Class II Reported ongoing
Distribution: USA Nationwide
Official source for Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, M... Jan 21, 2025 FDA drug enforcement
Out of Specification for Dissolution
Class II Reported ongoing
Distribution: Nationwide in the USA
Official source for Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKAR... Dec 18, 2024 FDA drug enforcement
LABELING: LABEL MIX-UP
Class III Reported ongoing
Distribution: Nationwide within the United States
Official source for Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL O... Dec 18, 2024 FDA drug enforcement
LABELING: LABEL MIX-UP
Class III Reported ongoing
Distribution: Nationwide within the United States
Official source for Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) b... Dec 4, 2024 FDA drug enforcement
Failed Dissolution Specifications
Class II Reported ongoing
Distribution: Nationwide USA
Official source for Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufac... Nov 27, 2024 FDA drug enforcement
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478,... Nov 27, 2024 FDA drug enforcement
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478,... Nov 27, 2024 FDA drug enforcement
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Class II Reported ongoing
Distribution: USA Nationwide
Official source for Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478,... Oct 18, 2024 FDA drug enforcement
Labeling: Label Mix-Up
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski,... Oct 18, 2024 FDA drug enforcement
Labeling: Label Mix-Up
Class II Reported ongoing
Distribution: Nationwide within the United States
Official source for Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, T... Mar 28, 2024 FDA drug enforcement
Microbial contamination of a non-sterile product: potential Bacillus cereus contamination.
Class I Reported terminated
Distribution: US Nationwide.
Official source for Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufa...
Reasons in these listed records Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution. Out of specification for dissolution. Failed Content Uniformity Specifications Presence of a foreign substance. These examples come from this result page and are not a ranking of every recall reason.
Checking AvKARE Is there a recall on avkare right now? This archive contains 20 records, including 19 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.
How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.
Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.
What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.
Where can I find older records? Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.