FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorporated
- Product
- Fresh Express Chopped Kit Bacon & Bleu 10.9 oz, UPC 07127930…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorporated
- Product
- Fresh Express Chopped Kit Asian 12 oz, UPC 071279302027, (C…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorporated
- Product
- Fresh Express America's Fresh 3 Color Deli Cole Slaw" 14 o…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorporated
- Product
- Fresh Express America's Fresh Old Fashioned Cole Slaw" 14oz,…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorporated
- Product
- Signature Farms Garden Salad, 12 oz, UPC 021130981359, Iceb…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorporated
- Product
- Fresh Express Iceberg Garden / Lechuga Repollo 24 oz., UPC 0…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Garland Ventures, LTD DBA Bally Plus
- Product
- Freshness Guaranteed Five Cheese Stuffed Shells Traditional…
- Reason
- Potential contamination with Listeria monocytogenes
- Published
- July 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
KIND LLC
- Product
- ***KIND HEALTHY GRAINS***Oats & Honey Granola with Toasted C…
- Reason
- Product contains undeclared sesame seeds.
- Published
- July 22, 2020
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Fresh Express Incorporated
- Product
- Little Salad Bar Garden, 12 oz, UPC 4099100082975, Iceberg l…
- Reason
- Ready to Eat salad products containing iceberg lettuce, red cabbage and/or carrot ingredients are recalled due to a possible health risk from Cyclospora.
- Published
- July 22, 2020
- Distribution
- Domestic: Midwestern states of AR, CT, D…
View recall →
FDA Recall
Terminated
Historical recordClass II
Cetrotide (cetrorelix acetate for Injection) 0.25 mg, Sterile - for subcutaneous use only, Rx Only, Manufactured for: EMD Serono, Inc., Rockland, MD 02370, NDC: 44087-1225-1
by EMD Serono, Inc.
- Reason
- Defective Container: Market complaints of missing rubber stoppers from drug vial. Missing rubber stoppers could lead to lack of sterility assurance.
- Published
- July 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Brimonidine Tartrate Opthalmic Solution 0.2%, 15 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-233-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
- Published
- July 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Brimonidine Tartrate Opthalmic Solution 0.2%, 10 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-232-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
- Published
- July 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Brimonidine Tartrate Opthalmic Solution 0.2%, 5 mL bottle, Rx only, Manufactured for: Somerset Therapeutics, LLC Hollywood, FL 33024. Made in India. NDC 70069-231-01
by SOMERSET THERAPEUTICS LLC
- Reason
- Failed Impurities/Degradation Specification: There is a slow leaching process from the product label on the bottle which may impact the product over the shelf life.
- Published
- July 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Zilretta (triamcinolone acetonide extended-release injectable suspension), 32mg per vial, 5mL vials, Single-dose Kits, Rx Only, Manufactured for: Flexion Therapeutics, Inc. 10 Mall Road, Suite 301, Burlington, MA 01803, NDC 70801-003-01
by Flexion Therapeutics, Inc.
- Reason
- Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertently distributed instead of discarded
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Childrens Dimetapp Cold & Cough, For ages 6 yrs. & over, 8 FL OZ. bottle, (237 mL), Distributed by: Pfizer Madison, NJ 07940, Made in Canada, UPC: 60300312234196, NDC: 0031-2234-19.
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Childrens Robitussin Honey Cough and Chest Congestion DM, dextromethorphan (cough suppressant), guaifenesin (expectorant), 4 FL OZ. bottle (118 mL), Distributed by: Pfizer, Madison, NJ 07940 USA, UPC: 50300318760128, NDC: 0031-8760-12.
by Glaxosmithkline Consumer Healthcare Holdings
- Reason
- Defective Delivery System: the dosing cups are missing graduations applicable to certain age groups.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distributed by: Major Pharmaceuticals, Livonia, MI 48152 NDC 00904-5794-61
by The Harvard Drug Group
- Reason
- CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Published
- July 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl Alcohol 68%), Manufactured by Beaming White LLC, 1205 NE 95th St., Vancouver, WA 98665
by Beaming White Llc
- Reason
- Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undeclared isopropyl alcohol.
- Published
- July 8, 2020
- 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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