Most Common Recall Reasons

Frequently cited reasons for FDA enforcement actions

Rank	Reason	Count
1	Lack of Assurance of Sterility	482
2	On 02/03/2023, FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine of Balt	409
3	CGMP Deviations	201
4	CGMP Deviations: Intermittent exposure to temperature excursion during storage.	198
5	Products may contain Salmonella	196
6	Due to a voluntary recall of low dead space syringes, and luer slip tip syringes	158
7	Products may be contaminated with Listeria monocytogenes.	143
8	Lack of assurance of sterility	135
9	cGMP deviations: Temperature abuse	130
10	cGMP deviations	127
11	Potential for backflow of medication from secondary (piggyback) IV containers in	116
12	Lack of Assurance of Sterility: after an FDA inspection called into question the	108
13	CGMP Deviations: product held outside appropriate storage temperature conditions	100
14	Lack of assurance of sterility. Validation data for decontamination cycles is la	95
15	Distribution without premarket approval/clearance.	92
16	Listeria Monocytogenes detected on food contact surfaces in Ready To Eat sandwic	86
17	CGMP Deviations: Firm went out of business and could no longer continue stabilit	86
18	Possible contamination with Listeria monocytogenes	74
19	Sponge forceps and towel clamps associated with small loose metal flakes potenti	73
20	Potential contamination with Salmonella Thompson	73
21	cGMP Deviations	72
22	Potential contamination with Listeria monocytogenes	72
23	CGMP Deviations: recalling drug products following an FDA inspection.	70
24	To provide clarification and labelling to define the useful life of ultrasound t	69
25	potential to be contaminated with Listeria monocytogenes	68
26	Complaints of reported separation of the Slider GDS Swivel Rod from the Swivel C	68
27	potential Salmonella	65
28	potential for contamination with listeria monocytogenes	60
29	Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at	59
30	Potential Salmonella Contamination	57
31	Failed Dissolution Specifications	56
32	Lack of assurance of sterility.	56
33	Failed Impurities/Degradation Specifications	55
34	Product may be contaminated with Listeria monocytogenes.	55
35	Product tested positive Salmonella .	54
36	Foreign material: pieces of a pen (writing utensil).	54
37	Lack of sterility assurance	54
38	Subpotent Drug	52
39	CGMP Deviations: Products were manufactured with contaminated excipient that was	51
40	Medical convenience kits contain plastic syringes affected by the FDA Safety Ale	49
41	Sedecal sent an email to its consignees to remind the users that the equipment i	46
42	CGMP Deviations: Products were exposed to temperatures outside of the products l	42
43	Potential Salmonella contamination.	41
44	Potential contamination with Listeria monocytogenes.	41
45	Listeria monocytogenes	40
46	Alcon has detected an increase in complaint reports related to sharpness for spe	40
47	Lack of Assurance of Sterility: FDA inspection raised sterility assurance concer	40
48	Ethylene Oxide/Ethylene Chlorohydrin (EO/ECH) residuals for the cast padding com	39
49	Lack of assurance of sterility: Lack of validation data for sanitization cycles	39
50	Out-of-specification test results obtained for identification testing based on H	39

Note: Reasons are grouped by the first 80 characters. Similar reasons with different wording may appear as separate entries.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.