FDA Recall
Ongoing
Historical recordClass II
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg per day 50/250 Twice Weekly Rx Only a) 2 Systems NDC 68968-0525-2; b) 8 Systems NDC 68968-0525-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
by Noven Pharmaceuticals Inc
- Reason
- Failed Stability Specifications; out of specification for shear.
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg per day, 50/140 Twice Weekly, Rx Only a) 2 Systems NDC 68968-0514-2 b) 8 Systems NDC 68968-0514-8, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186, Dist. by: Noven Therapeutics LLC, Miami, Florida 33186
by Noven Pharmaceuticals Inc
- Reason
- Failed Stability Specifications; out of specification for shear.
- Published
- August 25, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ethosuximide Oral Solution USP 250 mg/5 mL, 16 fl oz (473 mL), Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0670-16
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cimetidine Hydrochloride Oral Solution 300 mg/5 mL, 8 fl oz (237 mL) Rx ONLY, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0649-08
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, Rx ONLY, packaged in a) 16 fl oz (473 mL) NDC 0121-0868-16; b) 2 fl oz (60 mL) NDC 0121-0868-02; Manufactured by: Pharmaceutical Associates, Inc. Greenville, SC 29605
by PAI Holdings, LLC. dba Pharmaceutical Associates Inc
- Reason
- Lack of CGMP: This recall is being carried out due to potential for carry over of Senna Syrup.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sulfamethoxazole and Trimethoprim Tablets, USP, 800mg/160mg Double Strength, 500 Tablets, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-HIghtstown Road, EAs Windsor, NJ 08520, Made in India, NDC 65862-420-05
by Aurobindo Pharma USA Inc.
- Reason
- Presence of Foreign Substance- Potential of metal contamination.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Monfefo LLC
- Product
- Monfefo brand Turmeric Shot; 2oz; Cold Pressed Juice Blend;…
- Reason
- Product was not manufactured according to specifications.
- Published
- August 18, 2021
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Molly and Me Pecans
- Product
- MOLLY & ME PECANS all natural PRALINE PECANS, 4 oz., 7 oz.,…
- Reason
- The firm was notified during an inspection by the State that the product contains undeclared soy.
- Published
- August 18, 2021
- Distribution
- The product was shipped to the following…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods BABY NAPA KIMCHI in 128 oz, 64 oz, and 32 o…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods WHITE WHOLE KIMCHI in 128 oz, 64 oz, and 32…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG JULRADO SLICED CABBAGE KIMCHI in 128…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG JULRADO WHOLE CABBAGE KIMCHI in 128…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG SLICED CABBAGE KIMCHI in 5GAL plasti…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods NO MSG WHOLE CABBAGE KIMCHI in 5GAL plastic…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods JULRADO SLICED CABBAGE KIMCHI in 5GAL plast…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods JULRADO WHOLE CABBAGE KIMCHI in 5GAL plasti…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods WHOLE CABBAGE KIMCHI in 5GAL plastic tubs,…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
5000 Years Foods, Inc.
- Product
- 5000 Years Foods SLICED CABBAGE KIMCHI in 5GAL plastic tubs,…
- Reason
- potential to be contaminated with Listeria monocytogenes
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Slayer Forever, LLC dba BUBS Naturals
- Product
- BUBS Naturals MCT OIL Powder, Medium Chain Triglycerides fro…
- Reason
- Firm was notified by supplier of Medium Chain Triglycerides (MCT) that it contained undeclared milk allergens.
- Published
- August 18, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 45.0G (15 tea sachets per box), Manufactured by Havyco No. 45, Group 1, National Highway 14, Son Hiep Hamlet, Tho Son Commune, Bu Dang District, Binh Phuoc Province, Vietnam, Website: trathaomocgiamcan.com.
by Qikmoov LLC
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine.
- Published
- August 11, 2021
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
Read the full medical disclaimer.
