AvKARE: 20 recalls on record

Recalls filed with 1 agency: FDA (20).

First recall on record: April 24, 2024. Most recent: March 4, 2026.

Risk classification: Class I: 1 · Class II: 15 · Class III: 4

Most recent recalls

DateAgencyProduct
March 4, 2026FDAAmantadine HCl, Capsules, UPS, 100 mg, 50 Capsules (5 x 10) unit dose, Rx Only, Manufactu…D-0341-2026
January 14, 2026FDARosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manu…D-0292-2026
October 15, 2025FDANorgestimate and Ethinyl Estradiol Tablets, USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and…D-0007-2026
September 17, 2025FDAchloroproMAZINE Hydrochloride Tablets, USP, 50 mg, 50 Tablets (5x10) unit dose carton, Rx…D-0643-2025
September 17, 2025FDAchloroproMAZINE Hydrochloride Tablets, USP, 100 mg, 50 Tablets (5x10) unit dose carton, R…D-0644-2025
July 9, 2025FDAPitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pul…D-0529-2025
July 9, 2025FDAPitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for: AvKARE, Pul…D-0528-2025
June 18, 2025FDACelecoxib Capsules, 200 mg, 50 Capsules (5x10) Unit Dose per carton, Rx Only, Manufacture…D-0460-2025
June 18, 2025FDAChlorthalidone Tablets, USP, 25 mg, 50 Tablets (5x10) Unit Dose cards per carton, Rx only…D-0461-2025
February 26, 2025FDASilodosin Capsules, 8mg, 90-count bottle, Rx only, Manufactured for: AvKare, Pulaski, TN …D-0229-2025
February 19, 2025FDAIrbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured fo…D-0224-2025
January 8, 2025FDAPolyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (…D-0176-2025
January 8, 2025FDACarboxymethylcellulose Sodium Ophthalmic Solution 0.5% Moisturizing Lubricant Eye Drops, …D-0175-2025
January 8, 2025FDANitrofurantoin Capsules, USP, 100 mg, 50 Capsules (5 x 10) Unit Dose per carton, Rx Only,…D-0168-2025
December 11, 2024FDACinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, T…D-0108-2025
December 11, 2024FDACinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, T…D-0109-2025
December 11, 2024FDACinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, T…D-0110-2025
December 11, 2024FDASunitinib Malate Capsules, 25 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, Pu…D-0104-2025
December 11, 2024FDASunitinib Malate Capsules, 12.5 mg, 28-count bottles, Rx Only, Manufactured for: AvKARE, …D-0103-2025
April 24, 2024FDAAtovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cartons, Rx Only…D-0444-2024

Questions about this company

How many recalls does AvKARE have?
Recalert has 20 U.S. recalls on record for AvKARE, published between April 24, 2024 and March 4, 2026.
What was the most recent AvKARE recall?
FDA recall D-0341-2026, published March 4, 2026: 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.
Which agencies have handled AvKARE recalls?
AvKARE appears as the recalling firm in recalls from: FDA (20).

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