FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
New Century Snacks LLC
- Product
- Snak Club Tropical Trail Mix: 16 oz. plastic pouch: Ingr…
- Reason
- Firm was notified by customer that some bags of Tropical Trail mix contain Yogurt Trail mix and therefore do not declare milk, soy, wheat or cashews.
- Published
- June 20, 2018
- Distribution
- Alabama, Arizona, California, Colorado,…
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FDA Recall
Terminated
Historical recordClass I
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL
by HOSPIRA INC, LAKE FOREST
- Reason
- Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
- Published
- June 13, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Nystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
by Pharmaceutical Associates Inc
- Reason
- Resuspension problems: Out of specification for appearance and resuspendability.
- Published
- June 13, 2018
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
by Apotex Inc.
- Reason
- Presence of foreign substance: glass particles
- Published
- June 13, 2018
- Distribution
- Nationwide
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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
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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 I
Caudill Sprouting LLC
- Product
- Alfalfa Seeds
- Reason
- The firm's seeds have been linked in a multistate outbreak of Salmonella Montevideo and Salmonella Cubana infections.
- Published
- June 6, 2018
- Distribution
- The seeds were distributed to 6 consigne…
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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
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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 →
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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