FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Koffee Kup Bakery Inc.
- Product
- Koffee Kup Grinder Rolls-white 9' and Italian 9", packaged 2…
- Reason
- Baked bread products may contain foreign material-plastic pieces
- Published
- November 16, 2016
- Distribution
- VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Koffee Kup Bakery Inc.
- Product
- Koffee Kup Sandwich Rolls- Plain, packaged 17 oz and 27 oz
- Reason
- Baked bread products may contain foreign material-plastic pieces
- Published
- November 16, 2016
- Distribution
- VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Koffee Kup Bakery Inc.
- Product
- Koffee Kup Hamburger Buns- White, Wheat, Seeded -3 1/2" 4",…
- Reason
- Baked bread products may contain foreign material-plastic pieces
- Published
- November 16, 2016
- Distribution
- VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Koffee Kup Bakery Inc.
- Product
- Koffee Kup Hoogie Rolls- Wheat, Sourdough, Potatoe packaged…
- Reason
- Baked bread products may contain foreign material-plastic pieces
- Published
- November 16, 2016
- Distribution
- VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Koffee Kup Bakery Inc.
- Product
- Koffee Kup Kaiser Rolls: Egg, Plain, Corn, White, Wheat, Se…
- Reason
- Baked bread products may contain foreign material-plastic pieces
- Published
- November 16, 2016
- Distribution
- VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Koffee Kup Bakery Inc.
- Product
- Koffee Kup Potatoe Hamburger Buns, Plain and Seeded, 8 pk
- Reason
- Baked bread products may contain foreign material-plastic pieces
- Published
- November 16, 2016
- Distribution
- VT, NH, ME, MA, CT, RI, NY, NJ, PA, MD,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.
by PharMEDium Services, LLC
- Reason
- Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.
by Akorn Inc
- Reason
- Subpotent Drug: concentration of product is less than labeled amount.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess 24 FE 1.5/30 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, (a) 3 blisters (NDC 0603-7610-49), and (b) 6 blisters (NDC 0603-7610-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess FE 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP and ferrous fumarate tablets, USP 75 mg), 6 blisters (28 count), NDC 0603-7608-17, Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess FE 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0.02 mg, USP and ferrous fumarate tablets, USP 75 mg), 28 count, 6 blisters (NDC 0603-7609-17), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess 1/20 (norethindrone acetate, 1 mg and ethinyl estradiol tablets, 0,02 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7607-48) and (b) 6 blisters (NDC 0603-7607-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Gildess 1.5/30 (norethindrone acetate, 1.5 mg and ethinyl estradiol tablets, 0.03 mg, USP), 21 count, (a) 3 blisters (NDC 0603-7606-48) and (b) 6 blisters (NDC 0603-7606-15), Rx only, Manufactured in Canada By: Patheon, Inc., Ontario, Canada L5N 7K9, Manufactured for QUALITEST PHARMACEUTICALS, USA, Huntsville, AL 35811
by Par Pharmaceutical, Inc.
- Reason
- Subpotent Drug; Ethinyl Estradiol
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Ramipril Capsules, USP, 1.25 mg, 30-count bottle, Rx only, Manufactured by: Arrow Pharm (Malta) Ltd., Birzebbugia, BBG3000, Malta; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 16252-570-30.
by Actavis Laboratories, FL, Inc.
- Reason
- Labeling: Incorrect or Missing Lot And/or Exp Date: Bottles labeled with the incorrect expiration date of 03/18 rather than 09/17.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Oasis Foods Co
- Product
- Garden Harvest Buttermilk Ranch, Net contents: 1 GAL (3.8 L)…
- Reason
- Oasis is recalling several lots of the Select Recipe Buttermilk Ranch Dressing and the Garden Harvest Buttermilk Ranch because they were shipped with an incorrect label not listing Soy Lecithin as an ingredient in the ingredient statement or elsewhere on the display panel.
- Published
- November 9, 2016
- Distribution
- CO, CT, DC, FL, GA, MA, MD, NJ, NY, OH a…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
Oasis Foods Co
- Product
- Select Recipe Buttermilk Ranch Dressing, Net contents: 1 GAL…
- Reason
- Oasis is recalling several lots of the Select Recipe Buttermilk Ranch Dressing and the Garden Harvest Buttermilk Ranch because they were shipped with an incorrect label not listing Soy Lecithin as an ingredient in the ingredient statement or elsewhere on the display panel.
- Published
- November 9, 2016
- Distribution
- CO, CT, DC, FL, GA, MA, MD, NJ, NY, OH a…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Vitalicious Acquisition
- Product
- VitaTops Apple Crumb, NET WT. 2 oz. (55g), packed in a clear…
- Reason
- The affected lots of VitaTops Apple Crumb contain undeclared milk.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Roland Foods, LLC.
- Product
- Roland¿ Preserved Lemons, NET WT. 12.35 OZ., and Roland¿ PRE…
- Reason
- The product contains undeclared sulfites based on sampling and analysis by New York State Department of Agriculture and Markets and private laboratory testing.
- Published
- November 9, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60
by Janssen Ortho L.L.C.
- Reason
- Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.
- Published
- November 2, 2016
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25
by Boehringer Ingelheim Pharmaceuticals, Inc.
- Reason
- Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.
- Published
- November 2, 2016
- 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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