FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-30; c) 45 grams tube, NDC 52565-051-45; d) 60 grams tube, NDC 52565-051-60; Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310
by Teligent Pharma, Inc.
- Reason
- cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- Published
- March 30, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: August 1, 2022Historical recordClass I
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
by Blaine Labs Inc
- Reason
- Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
- Published
- March 30, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 8, 2024Historical recordClass II
Flow Beverages Inc.
- Product
- Flow Alkaline Spring Water - Organic lemon & ginger flavored…
- Reason
- Flow Beverages Inc., 33 Lakeview CT., Verona, VA, 24482 is initiating a recall of Flow Alkaline Spring Water - Organic lemon & ginger flavored water, 500 ml 12 units per case, Lots 2023AUG29 V5 and 2023AUG29 V5 because of four (4) customer complaints of alleged adverse reactions following the consumption of Flow organic lemon + ginger flavored water, 16.9 fl oz. (500 ml),
- Published
- March 30, 2022
- Distribution
- The product was distributed to the follo…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: March 8, 2024Historical recordClass II
Flow Beverages Inc.
- Product
- Flow Alkaline Spring Water - Organic lemon & ginger flavored…
- Reason
- Flow Beverages Inc., 33 Lakeview CT., Verona, VA, 24482 is initiating a recall of Flow Alkaline Spring Water - Organic lemon & ginger flavored water, 500 ml 12 units per case, Lots 2023AUG29 V5 and 2023AUG29 V5 because of four (4) customer complaints of alleged adverse reactions following the consumption of Flow organic lemon + ginger flavored water, 16.9 fl oz. (500 ml),
- Published
- March 30, 2022
- Distribution
- The product was distributed to the follo…
View recall →
FDA Recall
TerminatedTerminated: December 2, 2022Historical recordClass I
Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.
by Walmart Stores
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 16, 2023Historical recordClass II
0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20
by B. Braun Medical, Inc.
- Reason
- Lack of sterility assurance: leaking bags
- Published
- March 23, 2022
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 16, 2023Historical recordClass II
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
by The Harvard Drug Group
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: July 6, 2022Historical recordClass II
FDMR, INC DBA SUJI'S KOREAN CUISINE
- Product
- Taiyaki Variety Pack; 21.6 oz. (600g) 30 fish waffles in a…
- Reason
- Hazelnuts were declared in ingredient statement but not in Contains statement.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- WAP Honey BBQ Seasoning Net Wt 20.64 lbs. (9.36kg). Part…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- Maplewood Meats Honey BBQ Stick Seasoning Net Wt 21 lbs.…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- 796-B Honey Sriracha Snack Stick Seasoning Net Wt 5.25 l…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- Honey BBQ Snack Stick Seasoning packaged in the following si…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: October 19, 2022Historical recordClass III
PS Seasoning & Spices, Inc.
- Product
- Honey BBQ Snack, NO MSG Seasoning packaged in the following…
- Reason
- Undeclared wheat.
- Published
- March 23, 2022
- Distribution
- AR, CO, CT, FL, GA, IA, ID, IL, IN, KS,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 9, 2022Historical recordClass II
Swanson Health Products, Inc
- Product
- Swanson Ultra: Vitamin B12 Methylcobalamin High Absorption…
- Reason
- Dietary supplement may contain potential metal shavings greater than or equal to 7mm in length.
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 21, 2023Historical recordClass I
The Royal Ice Cream Company Inc.
- Product
- All Ice Cream and Ice Cream products within expiry; manufact…
- Reason
- Product may be contaminated with Listeria monocytogenes.
- Published
- March 23, 2022
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 24, 2022Historical recordClass I
Mohammad Mayha
- Product
- Helmi Honey VIP packaged in a gold paper box with black writ…
- Reason
- Contains hidden drug ingredient
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: June 24, 2022Historical recordClass I
Mohammad Mayha
- Product
- Jaguar Power Honey packaged in a gold paper box with black w…
- Reason
- Contains hidden drug ingredient
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: April 15, 2022Historical recordClass II
Herbalife International of America
- Product
- Herbalife NutritionProtein Bar Deluxe - Chocolate Peanut fla…
- Reason
- Undeclared allergen - egg
- Published
- March 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: July 16, 2023Historical recordClass II
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
by American Health Packaging
- Reason
- Impurity failure at 0-time of the repackaged lot.
- Published
- March 16, 2022
- 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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