FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Harmon Face Values, Saline Nasal Spray (sodium chloride), 0.65%, packaged as a) 1.5 FL OZ (44 mL) bottle UPC 7 27510 00501 0; b) 3 FL OZ (88 mL) bottle UPC 7 27510 00502 7, Distributed by Harmon Stores, Inc., Union, NJ 07083 USA.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) can, Distributed by: Midwood Brands, LLC, 10611 Monroe Rd., Matthews, NC 28105, UPC 0 32251 11617 9.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072, UPC 7 27510 00373 3 .
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 93351 01833 6; b) 1.5 FL OZ (45 mL) bottle UPC 0 93351 01834 3, Distributed by: Discount Drug Mart, 211 Commerce Drive, Medina, OH 44256
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Product #282476; and b) Net Wt. 0.5 OZ tube (14.2 g) UPC 0 50428 31746 4 Product #896071; Distributed by CVS Pharmacy, Inc,. One CVS Drive, Woonsocket, RI 02895.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 29380 5 Product #459367.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 41854 3.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium Chloride as Preservatives, 1.5 FL OZ (44 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 40814 8 Product #891465.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical recordClass II
CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (43 g) can UPC 0 50428 37079 7 Product #896831; b) Net Wt. 4.25 OZ (120 g) can UPC 0 50428 36124 5; c) Children's Net Wt. 2 OZ (57 g) can UPC 0 50428 58685 3 Product #282472, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
by Product Quest Manufacturing LLC
- Reason
- CGMP Deviations: products manufactured under conditions that could impact its product quality.
- Published
- October 24, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 30, 2021Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: May 7, 2020Historical 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
TerminatedTerminated: January 6, 2021Historical recordClass II
Lidl US TRADING
- Product
- Bellona brand Milk Chocolate Flavored Coated Wafer with Haz…
- Reason
- Lidl US has voluntarily recalled all Bellona brand Milk Chocolate Flavored Coated Wafer with Hazelnut Cr¿me Filling and White Chocolate Flavor confections as a precautionary measure because the allergen statement does not include wheat.
- Published
- October 24, 2018
- Distribution
- Product was sold at Lidl retail location…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 18, 2019Historical recordClass III
K.B. Pizza, Inc.
- Product
- Son of Italy Pepperoni Pizza Kit ,39 oz./2 pizzas per kit, N…
- Reason
- K.B. Pizza, Inc. has initiated a recall of Son of Italy Cheese Kit, Son of Italy Pepperoni Kit, 39 oz./2 pizzas per kit, Vacuum packed, 6 kits per case. Use by date of 12-5-18 on each kit and case, because the pizza kits were left at room temperature for 24 hours, with cheese packs in the kits.
- Published
- October 24, 2018
- Distribution
- All cases were distributed to the follow…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 18, 2019Historical recordClass III
K.B. Pizza, Inc.
- Product
- Son of Italy, Twin Pack Cheese Pizza Kit, 39 oz./2 pizzas pe…
- Reason
- K.B. Pizza, Inc. has initiated a recall of Son of Italy Cheese Kit, Son of Italy Pepperoni Kit, 39 oz./2 pizzas per kit, Vacuum packed, 6 kits per case. Use by date of 12-5-18 on each kit and case, because the pizza kits were left at room temperature for 24 hours, with cheese packs in the kits.
- Published
- October 24, 2018
- Distribution
- All cases were distributed to the follow…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 24, 2022Historical recordClass II
Harris Teeter
- Product
- Harris Teeter Low Fat FROZEN YOGURT cookies & cream 1.5 QUAR…
- Reason
- The firm was notified by a customer of peanut butter cups in the product. The product contains peanuts and coconut oil that is not listed in the ingredient statement.
- Published
- October 24, 2018
- Distribution
- Product was shipped to the following sta…
View recall →
FDA Recall
TerminatedTerminated: November 6, 2020Historical 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
TerminatedTerminated: March 26, 2019Historical 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
TerminatedTerminated: October 2, 2020Historical 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 →
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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