--- title: "AvKARE Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search AvKARE recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/avkare/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # AvKARE recall records **19** reported ongoing 20 records in this archive. Latest source date Feb 13, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Feb 13, 2026 FDA drug enforcement ### [Amantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-069-15.](https://isitonrecall.com/recall/fda-drug-d-0341-2026-amantadine-hcl-capsules-ups-100-mg-50-capsules-5-x-10-unit-dose-rx-only-manufactured-for-avkare-pula/) 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:...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0341-2026%22) Dec 31, 2025 FDA drug enforcement ### [Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15](https://isitonrecall.com/recall/fda-drug-d-0292-2026-rosuvastatin-tablets-usp-10-mg-rx-only-50-tablets-5-x-10-unit-dose-per-carton-manufactured-for-avkar/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0292-2026%22) Sep 2, 2025 FDA drug enforcement ### [Norgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg, 3 Units, 3x28 tablets blister cards per carton, Rx only, Manufactured...](https://isitonrecall.com/recall/fda-drug-d-0007-2026-norgestimate-and-ethinyl-estradiol-tablets-usp-0-18-mg-0-025-mg-0-215-mg-0-025-mg-and-0-25-mg-0-025/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0007-2026%22) Aug 25, 2025 FDA drug enforcement ### [chloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-164-15](https://isitonrecall.com/recall/fda-drug-d-0643-2025-chloropromazine-hydrochloride-tablets-usp-50-mg-50-tablets-5x10-unit-dose-carton-rx-only-manufacture/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0643-2025%22) Aug 25, 2025 FDA drug enforcement ### [chloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, Rx only, Manufactured for: AvKare, Pulaski, TN, 38478, NDC 50268-165-15](https://isitonrecall.com/recall/fda-drug-d-0644-2025-chloropromazine-hydrochloride-tablets-usp-100-mg-50-tablets-5x10-unit-dose-carton-rx-only-manufactur/) 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, ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0644-2025%22) Jun 26, 2025 FDA drug enforcement ### [Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-905-90](https://isitonrecall.com/recall/fda-drug-d-0528-2025-pitavastatin-tablets-1-mg-90-tablets-per-bottle-rx-only-manufactured-for-avkare-pulaski-tn-38478-ndc/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0528-2025%22) Jun 26, 2025 FDA drug enforcement ### [Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 42291-906-90](https://isitonrecall.com/recall/fda-drug-d-0529-2025-pitavastatin-tablets-2-mg-90-tablets-per-bottle-rx-only-manufactured-for-avkare-pulaski-tn-38478-ndc/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0529-2025%22) May 13, 2025 FDA drug enforcement ### [Celecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-169-15](https://isitonrecall.com/recall/fda-drug-d-0460-2025-celecoxib-capsules-200-mg-50-capsules-5x10-unit-dose-per-carton-rx-only-manufactured-for-avkare-pula/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0460-2025%22) May 9, 2025 FDA drug enforcement ### [Chlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-167-15](https://isitonrecall.com/recall/fda-drug-d-0461-2025-chlorthalidone-tablets-usp-25-mg-50-tablets-5x10-unit-dose-cards-per-carton-rx-only-manufactured-for/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0461-2025%22) Feb 4, 2025 FDA drug enforcement ### [Silodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN 38478, Manufactured by: Amneal Pharmaceuticals of NY, LLC, NY 11719, NDC 42291-778-90](https://isitonrecall.com/recall/fda-drug-d-0229-2025-silodosin-capsules-8mg-90-count-bottle-rx-only-manufactured-for-avkare-pulaski-tn-38478-manufactured/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0229-2025%22) Jan 21, 2025 FDA drug enforcement ### [Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15](https://isitonrecall.com/recall/fda-drug-d-0224-2025-irbesartan-tablets-usp-300-mg-50-tablets-5-x-10-unit-dose-per-carton-manufactured-for-avkare-pulaski/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0224-2025%22) Dec 18, 2024 FDA drug enforcement ### [Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by: AvKARE, Pulaski, TN, 38478, NDC 50268-068-15.](https://isitonrecall.com/recall/fda-drug-d-0175-2025-carboxymethylcellulose-sodium-ophthalmic-solution-0-5-moisturizing-lubricant-eye-drops-0-5-fl-oz-15/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0175-2025%22) Dec 18, 2024 FDA drug enforcement ### [Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15](https://isitonrecall.com/recall/fda-drug-d-0176-2025-polyvinyl-alcohol-ophthalmic-solution-1-4-moisturizing-lubricant-eye-drops-0-5-fl-oz-15-ml-bottles-d/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0176-2025%22) Dec 4, 2024 FDA drug enforcement ### [Nitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478. NDC#: 50268-625-15.](https://isitonrecall.com/recall/fda-drug-d-0168-2025-nitrofurantoin-capsules-usp-100-mg-50-capsules-5-x-10-unit-dose-per-carton-rx-only-manufactured-for/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0168-2025%22) Nov 27, 2024 FDA drug enforcement ### [Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30](https://isitonrecall.com/recall/fda-drug-d-0108-2025-cinacalcet-tablets-30-mg-30-count-bottle-rx-only-manufactured-for-avkare-pulaski-tn-38478-ndc-42291/) 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,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0108-2025%22) Nov 27, 2024 FDA drug enforcement ### [Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30](https://isitonrecall.com/recall/fda-drug-d-0109-2025-cinacalcet-tablets-60-mg-30-count-bottle-rx-only-manufactured-for-avkare-pulaski-tn-38478-ndc-42291/) 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,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0109-2025%22) Nov 27, 2024 FDA drug enforcement ### [Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30](https://isitonrecall.com/recall/fda-drug-d-0110-2025-cinacalcet-tablets-90-mg-30-count-bottle-rx-only-manufactured-for-avkare-pulaski-tn-38478-ndc-42291/) 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,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0110-2025%22) Oct 18, 2024 FDA drug enforcement ### [Sunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-901-28](https://isitonrecall.com/recall/fda-drug-d-0103-2025-sunitinib-malate-capsules-12-5-mg-28-count-bottles-rx-only-manufactured-for-avkare-pulaski-tn-38478/) 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,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0103-2025%22) Oct 18, 2024 FDA drug enforcement ### [Sunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 42291-902-28](https://isitonrecall.com/recall/fda-drug-d-0104-2025-sunitinib-malate-capsules-25-mg-28-count-bottles-rx-only-manufactured-for-avkare-pulaski-tn-38478-nd/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0104-2025%22) Mar 28, 2024 FDA drug enforcement ### [Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 50268-086-12.](https://isitonrecall.com/recall/fda-drug-d-0444-2024-atovaquone-oral-suspension-usp-750-mg-per-5-ml-sachets-20-units-x-5-ml-cartons-rx-only-manufactured/) 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...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0444-2024%22) ## 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](https://isitonrecall.com/guides/read-lot-codes/) 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](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/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. ## Keep checking [Search AvKARE](https://isitonrecall.com/check/?q=AvKARE) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)