Drug and pharmaceutical recalls
754 federal recalls in the last 12 months. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2026-07-08FDA-DrugACCORD HEALTHCARE, INC.Class IIAccord levothyroxine tablets recalled for subpotency
Subpotent Drug
- 2026-07-08FDA-DrugLupin Pharmaceuticals Inc.Class IILupin prednisolone acetate eye drops recalled for foreign substance
Presence of Foreign Substance
- 2026-07-08FDA-DrugACCORD BIOPHARMA INCClass IIAccord BioPharma IMULDOSA injection recalled for sterility concerns
Lack of assurance of Sterility:
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep CLear recalled for sterility assurance issue
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep CLear recalled for unsterilized applicators
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Scrub Teal recalled for sterility concerns
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Scrub Teal recalled for sterility risk
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Hi-Lite Orange recalled for sterility assurance
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Hi-Lite Orange recalled for sterility concerns
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IICareFusion ChloraPrep applicators recalled for sterility concerns
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Clear recalled for sterility concerns
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD PurPrep applicators recalled for sterility assurance issue
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Hi-Lite Orange recalled for sterility issue
Lack of assurance of sterility: Unsterilized ChloraPrep & PurPrep Applicators, intended for further processing and sterilization were instead distributed to customers outside of the intended distribution channel
- 2026-07-08FDA-DrugLupin Pharmaceuticals Inc.Not Yet ClassifiedLupin Glucagon Emergency Kit recalled for plunger defect
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
- 2026-07-01FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IISun Pharmaceutical Perampanel recalled for tablet strength mix-up
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
- 2026-07-01FDA-DrugElevate Oral CareClass IIElevate Oral Care Povi-One recalled for sub-potency
sub potency
- 2026-07-01FDA-DrugAnnora Pharma Private LimitedClass IICamber Lacosamide tablets recalled for Selexipag mix-up
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IBD ChloraPrep FREPP Clear recalled for sterility concerns
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IBD ChloraPrep Clear recalled for fungal contamination risk
Non-Sterility: Due to presence of Aspergillus penicillioides.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep FREPP Clear recalled for sterility risk
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- 2026-07-01FDA-DrugCareFusion 213, LLCClass IIBD ChloraPrep Clear recalled for sterility assurance concern
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
- 2026-07-01FDA-DrugPReye LLCClass IIPReye Vitamin See eye drops recalled for sterility concerns
Lack of Assurance of Sterility
- 2026-07-01FDA-DrugANI Pharmaceuticals, Inc.Class IIIANI Pharmaceuticals hydroxyzine solution recalled for foreign substance
Presence of foreign substance
- 2026-07-01FDA-DrugCentral Admixture Pharmacy Services, Inc.Class IICentral Admixture pediatric TPN bag missing required nutrients
Incorrect product formulation: bag did not contain copper and famotidine per label.
- 2026-07-01FDA-DrugDirect RxClass IIDirect Rx Duloxetine D/R recalled for impurity risk
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- 2026-07-01FDA-DrugAmgen, Inc.Class IIAmgen Sensipar cinacalcet tablets recalled for manufacturing deviations
CGMP Deviations
- 2026-07-01FDA-DrugAmgen, Inc.Class IIAmgen Corlanor recalled for foreign substance contamination
Presence of Foreign Substance.
- 2026-07-01FDA-DrugAmgen, Inc.Class IIAmgen Sensipar tablets recalled for manufacturing deviations
CGMP Deviations
- 2026-07-01FDA-DrugAmgen, Inc.Class IIAmgen Sensipar recalled for manufacturing quality deviations
CGMP Deviations
- 2026-07-01FDA-DrugAmgen, Inc.Class IIAmgen Corlanor heart medication recalled for foreign substance
Presence of Foreign Substance.
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