FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Desly International Corp.
- Product
- Melanie Mini Cookies with Caramel Flavor in a 17.6 oz (500g)…
- Reason
- Products contain undeclared peanuts.
- Published
- June 13, 2018
- Distribution
- CA CT FL GA IL KS KY MA MD ME…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Desly International Corp.
- Product
- Melanie Liubitelskie Cookies in a 17.6 oz (500g) clear plast…
- Reason
- Products contain undeclared peanuts.
- Published
- June 13, 2018
- Distribution
- CA CT FL GA IL KS KY MA MD ME…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Dean Foods, Inc.
- Product
- Baskin Robbins Mint Chocolate Chip
- Reason
- Product may contain unlabeled coconut.
- Published
- June 13, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Lake Michigan Distilling Co LLC
- Product
- Ethanol Extraction 190 Proof Non-Denatured Grain Alcohol, M…
- Reason
- Lake Michigan Distilling, LLC, dba Ethanol Extraction has initiated a voluntary recall of Ethanol Extraction s 190 Proof Non-Denatured Grain Alcohol due to contamination with methanol which could cause serious injury or death if consumed.
- Published
- June 13, 2018
- Distribution
- Domestic: AK, AL, AR, AZ, CA, CO, CT, DC…
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FDA Recall
Terminated
Historical recordClass I
7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
by Shoreside Enterprises Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- June 6, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
POSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
by Shoreside Enterprises Inc.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- Published
- June 6, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
JJBL LLC
- Product
- The Most Awesome Chocolate Bar EVER, packaged individually i…
- Reason
- The Most Awesome Chocolate Bar EVER is recalled due to undeclared wheat.
- Published
- June 6, 2018
- Distribution
- Distributed in CA, OR, and WA.
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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…
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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…
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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…
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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…
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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
🇺🇸 United States
Terminated
Historical recordClass I
Ziyad Brothers Importing, Inc.
- Product
- Ziyad Brand Tahini, 8oz, 16oz, ¿ gal, 32oz. , packed in glas…
- Reason
- Ziyad Brothers Importing is voluntarily recalling its Ziyad Brand Tahini, 8 oz. 16 oz., 1/2 gallon and 32 oz. sizes due to potential contamination with Salmonella.
- Published
- June 6, 2018
- Distribution
- Domestic: AL, AR, AZ, CA, CT, DE, FL, GA…
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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 →
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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