FDA Recall
Terminated
Historical recordClass II
Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6001-25, Vial NDC# 0641-6001-01
by Hikma Pharmaceuticals USA Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, Manufactured by West-Ward Eatontown, NJ 07724, Carton NDC# 0641-6044-25, Vial NDC# 0641-6044-01
by Hikma Pharmaceuticals USA Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification results observed for total related compounds during testing of retain samples.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc,m USA, Mahwah, NJ 07430, NDC 68462-841-13.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/25 mg, 30 Tablets, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot no 2, Phase-2, Pharma Zone, SEZ Pithampur, District Dhar, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430, NDC 68462-842-13.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NATURE'S SUNSHINE PRODUCTS
- Product
- Aivia Whey Protein+ Power Herbs Vanilla Bean, NET WT. 1.33 L…
- Reason
- Label declares Whey but does not declare Milk.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
NATURE'S SUNSHINE PRODUCTS
- Product
- Aivia Whey Protein+ Power Herbs Chocolate, NET WT 1.35 LBS (…
- Reason
- Label declares Whey but does not declare Milk.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BrandStorm Inc
- Product
- Natierra Nature & Earth Organic Blueberries Ingredients: Org…
- Reason
- Elevated levels of lead detected as a result of testing conducted by Maryland Department of Health.
- Published
- August 17, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Refresco Beverages US Inc
- Product
- Clear American brand "Strawberry Punch Snow Cone" flavored s…
- Reason
- The product may contain trace amounts of coconut, which is not declared on the labeling. Laboratory analysis was unable to detect any coconut allergen, however the firm has decided to recall out of an abundance of caution.
- Published
- August 17, 2022
- Distribution
- Stores throughout AZ, CA, IL, IN, KY, ME…
View recall →
FDA Recall
Terminated
Historical recordClass I
SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.
by Ultra Supplement LLC
- Reason
- Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
by Distributor RFR, LLC.
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Defective Container: Tube split from side seam
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-count bottles, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL USA 33314, USA, Distributed by: Actavis Pharma Inc., Parsippany, NJ 07054 USA; NDC 58544-692-30.
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications: below specification limits for dissolution.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA; NDC 52544-691-30.
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications: below specification limits for dissolution.
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks ZzzQuil Liquid Melatonin Syrup Adult 8oz plastic bott…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks ZzzQuil Liquid Melatonin Syrup Pediatric 8oz plastic…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks Children's Botanicals Liquid Nighttime 4oz plastic bo…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks Children's Botanicals Liquid Daytime 4oz plastic bott…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
The Procter & Gamble Company
- Product
- Vicks Children's Botanicals Liquid Daytime/Nighttime Combo P…
- Reason
- Acidified/Low Acid dietary supplement with no approved process.
- Published
- August 10, 2022
- Distribution
- Alaska, Alabama, Arkansas, Arizona, Cali…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Shopaax.com
- Product
- Kingdom Honey Royal Honey VIP The Ultimate Power Source; 12…
- Reason
- Undeclared Sildenafil
- Published
- August 10, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Vitamin Cottage Natural Food Markets, Inc.
- Product
- Amaranth Grain Organic, brand Natural Grocers, packaged in p…
- Reason
- Potential to be contaminated with Salmonella
- Published
- August 10, 2022
- Distribution
- Multiple states
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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