FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Morski Brands Inc. dba Dawn's Fresh Foods
- Product
- Sully's Potato Salad, Mfg. No. 10125, Net Wt. 10 lbs. (4.54k…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- June 6, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Morski Brands Inc. dba Dawn's Fresh Foods
- Product
- Finest Traditions Deluxe Potato Salad, Packaged into the fol…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- June 6, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Morski Brands Inc. dba Dawn's Fresh Foods
- Product
- Dawn's Foods Deluxe Potato Salad Mfg. No. 20114, Net Wt. 30…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- June 6, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Morski Brands Inc. dba Dawn's Fresh Foods
- Product
- Terry's Potato Salad, Packaged into the following sized cont…
- Reason
- Product has the potential to be contaminated with Listeria monocytogenes.
- Published
- June 6, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks NUTS ALMOND RAISIN Mix Net Wt. 1.6 oz (#g) DI…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks Raw ALMONDS Net Wt. 1.3 oz (#g) DISTRIBUTED B…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks Honey Roasted CASHEWS Net Wt. 1.2 oz (#g) DIS…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Liberty Snacks Natural PISTACHIOS Net Wt. 1 oz (#g) DISTRIBU…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Hickory Harvest Island Fruit Mix NET WT 9 oz (255g) Distribu…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Ohio Hickory Harvest Brand Products Inc.
- Product
- Heinens Organic Nut Mix Net Wt. 9 oz (255g) Distributed By H…
- Reason
- The firm received positive test results for Listeria monocytogenes in a product that was housed in the same storage bin.
- Published
- June 6, 2018
- Distribution
- Product was only distributed in the foll…
View recall →
FDA Recall
Terminated
Historical recordClass II
My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.
by Lupin Pharmaceuticals Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
by Lupin Pharmaceuticals Inc.
- Reason
- Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.
by Ideaz Llc
- Reason
- CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
by Exela Pharma Sciences LLC
- Reason
- Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
by Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- Reason
- GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Rhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
by AMA Wholesale
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.
by Ideaz Llc
- Reason
- CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Nature's Only Choice
- Product
- Nature's Only Choice B17 BITTER RAW APRICOT EXTRACT AMYGDALI…
- Reason
- The Vitamin B17 containing product is considered to be a prescription drug, new drug, and unapproved new drug.
- Published
- May 30, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
- Published
- May 23, 2018
- 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.
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