FDA enforcement

FDA recalls

Browse 86,532 U.S. Food & Drug Administration product recalls and enforcement actions, by company.

Abbott Laboratories — Zemplar (paricalcitol) Injection, 5 mcg/mL in 2 mL multi-dose vials, …Class II · 2012-05-14
Abbott Laboratories — Synthroid (levothyroxine sodium) Tablets USP, 50 mcg, Rx Only, 90-Cou…Class II · 2012-07-19
Abbott Laboratories — Synthroid (levothyroxine sodium) Tablets USP, 75 mcg, Rx Only, 90-Cou…Class II · 2012-07-19
Abbott Laboratories — Synthroid (levothyroxine sodium) Tablets USP, 112 mcg, Rx Only, 90-Co…Class II · 2012-07-19
Abbott Laboratories — Abbott Calcilo XD, Low-calcium Vitamin D-Free Infant formula with iro…Class II · 2019-09-13
Abbott Laboratories — Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable…Class II · 2022-10-13
Abbott Laboratories — Pedialyte Unflavored (Export to Canada) 2 fl oz plastic reclosable bo…Class II · 2022-10-13
Abbott Laboratories — Similac 360 Total Care 2 fl oz reclose able plastic bottle Packaged …Class II · 2022-10-13
Abbott Laboratories — Similac 360 Total Care/Similac 360 Total Care Sensitive Discharge Kit…Class II · 2022-10-13
Abbott Laboratories — Similac 360 Total Care Sensitive 2 fl oz reclose able plastic bottle …Class II · 2022-10-13
Abbott Laboratories — Similac 360 Total Care Sensitive with Nipples 2 fl oz reclose able pl…Class II · 2022-10-13
Abbott Laboratories — Similac Neosure 2 fl oz reclose able plastic bottle Packaged as: 48 …Class II · 2022-10-13
Abbott Laboratories — Similac Total Comfort 2 fl oz reclose able plastic bottle Packaged a…Class II · 2022-10-13
Abbott Laboratories — Similac Special Care 2 fl oz reclose able plastic bottle Packaged as…Class II · 2022-10-13
Abbott Laboratories — Similac Stage 1 (Export Colombia) 2 fl oz reclose able plastic bottle…Class II · 2022-10-13
Abbott Laboratories — Similac Stage 1 (Export Dominican Republic) 2 fl oz reclose able plas…Class II · 2022-10-13
Abbott Laboratories — Similac Water - Sterilized (Export Canada) 2 fl oz reclose able plas…Class II · 2022-10-13
Abbott Laboratories — Similac Probiotic Tri-Blend - 0.017oz (0.50g) packaged in foil packet…Class II · 2023-10-31
Abbott Laboratories — Zone Perfect Fudge Graham bar 50g bars packaged in foil wrapped- 12 b…Class II · 2023-03-28
Abbott Laboratories — Abbott EleCare Infant Formula Unflavoured 400g can. 6 cans per case.…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Human Milk Fortifier 0.9g Pouch / Sachet, 50 Pouch / S…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Alimentum Toddler Drink 12.1oz. can. 6 cans per case.…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Total Comfort 12.6oz. can. 6 cans per case. Item n…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac for Supplementation 22oz. plastic jar. 4 jars per cas…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac For Spit Up Infant Formula with Iron 22.5oz plastic ja…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Advance Step-1 22oz. plastic jar and 34 oz. can. 6 un…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Advance Step-2 22.5oz. plastic jar. 6 jars per case. …Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Sensitive Lactose Sensitivity 22oz. plastic jar. 6 ja…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Alimentum Infant Formula with Iron 12oz. can. 6 jars …Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Total Comfort 638g. plastic jar and 8oz. can. 6 units…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac EleCare HMO, Abbott Similac EleCare, Abbott EleCare Si…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Pro-Sensitive Infant Formula with Iron 20.1oz. and 22.…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Pro-Advance Infant Formula with Iron 20.6oz. and 23.2o…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Pro-Advance 23oz. and 34oz. plastic jar. 6 jars per ca…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Pro-Advance 20.6oz., 30.3oz., 34oz., and 658g plastic …Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Pro-Total Comfort Infant Formula with Iron 20.1oz. and…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Advance Infant Formula with Iron 12.4oz. can, 23.2oz. …Class I · 2022-02-17
Abbott Laboratories — Abbott Alimentum, Abbott Similac Alimentum, Abbott Similac Alimentum …Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Sensitive Infant Formula with Iron 22.5oz. plastic jar…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Sensitive 34oz. plastic jar. 6 jars per case. Abbott…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Total Comfort Infant Formula with Iron 12.6oz. can. 6 …Class I · 2022-02-17
Abbott Laboratories — Abbott Similac For Spit Up Infant Formula with Iron 12.5oz. can. 6 ca…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac For Spit Up Infant Formula with Iron 7oz. can and 19.5…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Alimentum with 2'-FL HMO, Abbott Similac Alimentum HMO…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac 360 Total Care Infant Formula with Iron 20.6oz. and 30…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Organic with A2 Milk Toddler Drink 23.2oz plastic jar.…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Organic 7oz. can. 6 cans per case. Abbott Similac Org…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Organic with A2 Milk Infant Formula with Iron 8oz. and…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac 360 Total Care Sensitive Infant Formula with Iron 7oz.…Class I · 2022-02-17
Abbott Laboratories — Abbott EleCare, EleCare LCP Hypoallergenic, Similac EleCare 400g. can…Class I · 2022-02-17
Abbott Laboratories — Abbott EleCare Amino Acid-Based Powder Infant Formula with Iron 14.1o…Class I · 2022-02-17
Abbott Laboratories — Abbott EleCare Junior Vanilla 14.1oz. can and Abbott EleCare Jr Simil…Class I · 2022-02-17
Abbott Laboratories — Abbott EleCare Jr Amino Acid-Based Nutrition Powder Unflavored 14.1oz…Class I · 2022-02-17
Abbott Laboratories — Abbott EleCare Jr Amino Acid-Based Nutrition Powder Banana 14.1oz. ca…Class I · 2022-02-17
Abbott Laboratories — Abbott EleCare Jr Amino Acid-Based Nutrition Powder Chocolate 14.1oz.…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Alimentum 400g. can. 6 cans per case. Item number…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Alimentum Allergies & Colic Hypoallergenic Infant Form…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac Alimentum Eye Q Plus 400g. can. Abbott Alimentum Eye Q…Class I · 2022-02-17
Abbott Laboratories — Abbott Infant Formula Powder 12.6oz. can. 6 cans per case. Item n…Class I · 2022-02-17
Abbott Laboratories — Abbott Similac PM 60/40 Low Iron Infant Formula, 14.1oz. can. 6 cans …Class I · 2022-02-17
Abbott Laboratories — Pedialyte***Replaces Electrolytes***Great for Kids and Adults***Straw…Class III · 2022-06-03
Abbott Laboratories — Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Peach Ma…Class II · 2022-06-03
Abbott Laboratories — Pedialyte with Immune Support***+Zinc/Selenium & Magnesium***Raspberr…Class II · 2022-06-03
Abbott Laboratories — Similac¿ Advance Complete Nutrition Infant Formula with Iron, 1.45lb …Class II · 2015-01-28
Abbott Laboratories — Abbott Jevity Complete, Balanced Nutrition with Fiber Ready to Hang e…Class II · 2022-07-03
Abbott Laboratories — HbA1c Calibrators LN 4P52-02 consists of: 4P52-02 Hemoglobin A1c 1 x …Class II · 2014-04-30
Abbott Laboratories — Emerald Diluent Tubing, List number 09H50-01, accompanying CELL-DYN E…Class II · 2019-05-09
Abbott Laboratories — ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 0…Class II · 2021-09-29
Abbott Laboratories — ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8…Class II · 2021-09-29
Abbott Laboratories — ARCHITECT Lactic Acid Part # 09D891T21 The Lactic Acid assay is us…Class II · 2016-10-11
Abbott Laboratories — Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer M…Class II · 2025-09-18
Abbott Laboratories — Abbott CELL-DYN Ruby, Model CD-Ruby, List number 08H67-01, and Abbott…Class II · 2023-10-19
Abbott Laboratories — Alinity ci-series System Control Module, REF: 03R70-01Class II · 2023-05-30
Abbott Laboratories — Alinity i Processing Module REF 03R65-01 The Alinity i Processin…Class II · 2023-10-19
Abbott Laboratories — Alinity c Processing Module REF 03R67-01 The Alinity c Processin…Class II · 2023-10-19
Abbott Laboratories — ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40…Class II · 2023-10-19
Abbott Laboratories — Abbott Laboratories, ARCHITECT 25-OH Vitamin D Reagent Kit, 03L52-25 …Class II · 2012-12-12
Abbott Laboratories — ARCHITECT STAT Myoglobin Calibrators, RES 2K43-01 The ARCHITECT ST…Class II · 2022-03-08
Abbott Laboratories — Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i System…Class III · 2022-11-24
Abbott Laboratories — Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20Class II · 2025-11-13
Abbott Laboratories — CELL-DYN Emerald analyzer, REF 09H39-01. The CELL-DYN Emerald is …Class II · 2019-02-20
Abbott Laboratories — ARCHITECT Sirolimus Calibrators - Product Usage: The ARCHITECT Siroli…Class III · 2019-04-09
Abbott Laboratories — ARCHITECT HbA1C Calibrators - Product Usage: The ARCHITECT HbA1c Cali…Class III · 2019-04-09
Abbott Laboratories — ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact P…Class III · 2019-04-09
Abbott Laboratories — ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intac…Class III · 2019-04-09
Abbott Laboratories — ARCHITECT STAT High Sensitive Troponin-I Controls - Product Usage: Th…Class III · 2019-04-09
Abbott Laboratories — ARCHITECT STAT High Sensitive Troponin-I Calibrators - Product Usage:…Class III · 2019-04-09
Abbott Laboratories — ALINITY i Anti-TPO Calibrators - Product Usage: The Alinity i Anti-TP…Class III · 2019-04-09
Abbott Laboratories — Technopath Multichem S Plus Level 1 - Product Usage: Multichem S Plus…Class III · 2019-04-09
Abbott Laboratories — Technopath Multichem S Plus Level 2 - Product Usage: Multichem S Plus…Class III · 2019-04-09
Abbott Laboratories — CELL-DYN Ruby System: List Number: 08H6701; Hematology: The CE…Class II · 2017-02-13
Abbott Laboratories — REF: 4P52-20 Hemoglobin A1c for use with Architect, IVD, CE, R1 1 x 5…Class II · 2022-06-09
Abbott Laboratories — REF: 08P4320, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.…Class II · 2022-06-09
Abbott Laboratories — REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.…Class II · 2022-06-09
Abbott Laboratories — ARCHITECT STAT Myoglobin Reagent Kit, LN 2K43-25 and 2K43-20.Class II · 2024-02-21
Abbott Laboratories — CELL-DYN Emerald Cleaner, product number 09H46-02. 960mL. IVD; …Class II · 2016-03-24
Abbott Laboratories — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Class II · 2025-03-18
Abbott Laboratories — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Class II · 2025-03-18
Abbott Laboratories — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Class II · 2025-03-18
Abbott Laboratories — Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog…Class II · 2025-03-18