FDA Recall
Terminated
Historical recordClass II
DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Distributed by: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 0 20908 05100 3.
by Product Quest Manufacturing LLC
- Reason
- Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA
by Humco Holding Group, Inc
- Reason
- CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA
by Humco Holding Group, Inc
- Reason
- CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501
by Humco Holding Group, Inc
- Reason
- CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
COCA COLA BOTTLING COMPAN
- Product
- Sprite 12 FL OZ (355 mL) CONTAINS PHENYLALANINE CAFFEINE FRE…
- Reason
- Product contains plastic material.
- Published
- October 24, 2018
- Distribution
- Product was shipped to IL, IN, KY, MI, O…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
COCA COLA BOTTLING COMPAN
- Product
- NO SUGAR NO CALORIES Diet Coke 12 FL OZ (355 mL) CONTAINS PH…
- Reason
- Product contains plastic material.
- Published
- October 24, 2018
- Distribution
- Product was shipped to IL, IN, KY, MI, O…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
COCA COLA BOTTLING COMPAN
- Product
- CAFFEINE FREE Diet Coke 12 FL OZ (355 ml) CONTAINS PHENYLALA…
- Reason
- Product contains plastic material.
- Published
- October 24, 2018
- Distribution
- Product was shipped to IL, IN, KY, MI, O…
View recall →
FDA Recall
Terminated
Historical recordClass II
Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (NDC: 0067-6286-14), 2 bottles (NDC: 0067-6286-28) or 3 bottles (NDC: 0067-6286-42), Over-the-counter, Distributed By: GSK Consumer Healthcare, Warren, NJ 07059.
by GLAXOSMITHKLINE NEBRASKA
- Reason
- CGMP deviations
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablets. Manufactured by Laboratories Leon Farma S.A., Spain, for Xiromed, LLC., Florham Park, NJ 07932. Product of Spain NDC 70700-116-85 (I unit x 28 tablets 70700-116-84)
by Xiromed LLC
- Reason
- Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-6729-03.
by Pfizer Inc.
- Reason
- Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
by InvaGen Pharmaceuticals, Inc.
- Reason
- Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
by Pfizer Inc.
- Reason
- CGMP Deviations; rejected product was used to manufacture final bulk lot
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sarap Asian Fusion
- Product
- Ube Cookies & Cream (cookies); A Sarap Asian Fusion Product…
- Reason
- Undeclared wheat, soy lecithin, and milk
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sarap Asian Fusion
- Product
- Matcha Chocolate (cookies); A Sarap Asian Fusion Product;…
- Reason
- Undeclared wheat and soy lecithin
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sarap Asian Fusion
- Product
- Black Sesame White Chocolate (cookies); A Sarap Asian Fusio…
- Reason
- Undeclared wheat, soy lecithin, and milk
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Sarap Asian Fusion
- Product
- Miso Milo Chocolate (cookies); A Sarap Asian Fusion Product…
- Reason
- Undeclared wheat and soy lecithin
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Brand White Corn Chips, Salted NET WT 20…
- Reason
- Product may contain undeclared milk.
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02
by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Reason
- Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01
by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Reason
- Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
- Published
- October 10, 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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