FDA Recall
🇺🇸 United States
TerminatedTerminated: March 13, 2020Historical recordClass II
Back Roads Food Company
- Product
- Back Roads Granola: Maple Pecan Best by date: 01/11/20-02/…
- Reason
- Products may contain pieces of aluminum.
- Published
- May 22, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 13, 2020Historical recordClass II
Back Roads Food Company
- Product
- Back Roads Granola: Coconut Ginger Best by date: 01/11/20-…
- Reason
- Products may contain pieces of aluminum.
- Published
- May 22, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 13, 2020Historical recordClass II
Back Roads Food Company
- Product
- Back Roads Granola: Coconut Crunch Best by date: 01/11/…
- Reason
- Products may contain pieces of aluminum.
- Published
- May 22, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 13, 2020Historical recordClass II
Back Roads Food Company
- Product
- Back Roads Granola: Original Best by date: 01/11/20-02/2…
- Reason
- Products may contain pieces of aluminum.
- Published
- May 22, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 13, 2020Historical recordClass II
Back Roads Food Company
- Product
- Back Roads Granola: Gluten Free Best by date: 01/11/20-02/…
- Reason
- Products may contain pieces of aluminum.
- Published
- May 22, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 13, 2020Historical recordClass II
Back Roads Food Company
- Product
- Back Roads Granola: Dark Chocolate Pecan Best by date: 01/1…
- Reason
- Products may contain pieces of aluminum.
- Published
- May 22, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 13, 2020Historical recordClass II
Back Roads Food Company
- Product
- Back Roads Granola: Ancient Grains Best by date: 01/11/20-0…
- Reason
- Products may contain pieces of aluminum.
- Published
- May 22, 2019
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 23, 2020Historical recordClass I
Jensen Tuna Inc
- Product
- Frozen ground tuna, 1 lb package, 20 packages/case
- Reason
- Potential to be contaminated with Salmonella.
- Published
- May 22, 2019
- Distribution
- Multiple states
View recall →
FDA Recall
TerminatedTerminated: June 20, 2023Historical recordClass I
Mycophenolate Mofetil for Injection, USP 500 mg, 4 Single Dose Vials, Rx Only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977 NDC 342023-172-044
by Par Pharmaceutical, Inc.
- Reason
- Presence of Particulate Matter; glass fragment observed in one vial of reconstituted product
- Published
- May 15, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 14, 2019Historical recordClass I
FENTANYL Transdermal System, 12 mcg/h, five (12 mcg/h) systems per carton, Rx only, Distributed by: Alvogen, Inc., Pine Brook, NJ 07058; Manufactured by: 3M Drug Delivery Systems, St. Paul, MN 55107, NDC 47781-423-47.
by Alvogen, Inc
- Reason
- Product Mix-Up: Customer complaint that their carton labeled as Fentanyl Transdermal Systems, 12 mcg/h contained five patches labeled and containing 50 mcg/h.
- Published
- May 15, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 28, 2020Historical recordClass II
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02
by Sagent Pharmaceuticals Inc
- Reason
- Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
- Published
- May 15, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 29, 2021Historical recordClass II
Carvedilol Tablets, USP, 6.25 mg, 500 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-093-05
by Zydus Pharmaceuticals USA Inc
- Reason
- Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
- Published
- May 15, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 29, 2021Historical recordClass II
Acyclovir Tablets, USP, 400 mg, 100 count bottles, Rx Only Manufactured by: Cadila Healthcare Ltd., India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ USA 08534 NDC 68382-791-01
by Zydus Pharmaceuticals USA Inc
- Reason
- Labeling; Label Mix-up; report received of one bottle labeled as Acyclovir Tablets USP 400 mg actually contained Carvedilol Tablets 6.25 mg
- Published
- May 15, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 12, 2019Historical recordClass II
Oregons Wild Harvest Inc
- Product
- Dried whole elderberry, Oregon s Wild Harvest brand, package…
- Reason
- Dried whole Elderberries are recalled due to glass fragments contamination.
- Published
- May 15, 2019
- Distribution
- CA, FL, GA, HI, ID, IL, MD, ME, MN, NH,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 15, 2019Historical recordClass II
Wegmans Food Markets, Inc.
- Product
- Wegmans Food You Feel Good About Cilantro Lime Green Sauce.…
- Reason
- Product may contain foreign material
- Published
- May 15, 2019
- Distribution
- MA, NY, PA, NJ, MD, and VA
View recall →
FDA Recall
TerminatedTerminated: February 11, 2021Historical recordClass III
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%; full case of 12-2 oz. cans only; Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; Product Code 80-6802; Case UPC 1 03 16864 68002 7.
by Advantice Health
- Reason
- Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 11, 2021Historical recordClass III
Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 20%, 0.5%, Net WT 2.75 oz (78g); Distributed by Moberg Pharma North America LLC, Cedar Knolls, NJ 07927; UPC 8 51409 00722 6
by Advantice Health
- Reason
- Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
- Published
- May 8, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
GlipiZIDE Extended-release Tablets, 2.5 mg, 30 Tablets (3 x 10), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC: 68084-295-21
by American Health Packaging
- Reason
- Failed Dissolution Specifications: dissolution failure at time zero of the repackaged lot. Drug release results were slightly above specification at time zero.
- Published
- May 8, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 17, 2022Historical recordClass II
Revonto (dantrolene sodium for injection), 20 mg/vial, For treatment of malignant hyperthermia, For Intravenous Use Only, Rx Only, Made in Italy, Dist. by: US WorldMeds, LLC, Louisville, KY 40241, NDC: 27505-003-67
by US Worldmeds LLC
- Reason
- Presence of Precipitate: Appearance is Out of Specification for the reconstituted solution during 24-month stability time point analysis.
- Published
- May 8, 2019
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 16, 2021Historical recordClass II
BEVACIZUMAB 1.25 mg/0.05 mL 31G MJ syringe Intravitreal Injection. This biologic product was repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901 Lot:190212AB BUD:5/13/2019, Repackaged on 2/12/2019
by Pacifico National, Inc. dba AmEx Pharmacy
- Reason
- Defective Delivery System: difficult to express
- Published
- May 8, 2019
- 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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