AvKARE, Inc.

50 FDA enforcement records linked to this company.

• recall — Class II2026-03-04

  Failed Dissolution Specifications: This recall has been initiated due to an Out of Specification finding in dissolution.

• recall — Class II2026-01-14

  Out of specification for dissolution.

• recall — Class II2025-10-15

  Failed Content Uniformity Specifications

• recall — Class II2025-09-17

  Presence of a foreign substance.

• recall — Class II2025-09-17

  Presence of a foreign substance.

• recall — Class III2025-07-09

  Failed Impurity/Degradation Specifications

• recall — Class III2025-07-09

  Failed Impurity/Degradation Specifications

• recall — Class II2025-06-18

  Failed Dissolution Specifications

• recall — Class II2025-06-18

  Presence of Foreign Tablets/Capsules: manufacturer recalled because one tadalafil 5mg tablet was found in 500 count bottle of Celecoxib 200 mg capsules

• recall — Class II2025-02-26

  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%)

• recall — Class II2025-02-19

  Out of Specification for Dissolution

• recall — Class II2025-01-08

  Failed Dissolution Specifications

• recall — Class III2025-01-08

  LABELING: LABEL MIX-UP

• recall — Class III2025-01-08

  LABELING: LABEL MIX-UP

• recall — Class II2024-12-11

  CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.