FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
ZRECT for Women Herbal Dietary Supplement Capsules, 500 mg, supplied in 30 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229055
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
ENHANCEROL Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
BIGnHARD Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY ---- UPC Code 680474229086
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
ZDaily Daily Testosterone and Llibido Booster Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 680474229062
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
TORNADO Male Enhancement Herbal Dietary Supplement Capsules, Over 4000 mg value, supplied in 2, 4 and 10 count packages, Made in USA Distributed by American Health Supplements, Chicago, Illinois --- UPC Code 680474228959
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
RECTALIS Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Cheyenne, WY --- UPC Code 680474228782
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Xrect Male Enhancement Herbal Dietary Supplement Capsules, 500 mg supplied in 2, 4 and 10 count packages, Distributed by Organic Herbal Supply, Roseville, CA ---- UPC Code 680474015795
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
ZRECT Male Enhancement Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Organic Herbal Supply, Roseville, CA --- UPC Code 852675999451
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
Cummor Natural Male Enhancement, Herbal Dietary Supplement Capsules, 500 mg, supplied in 2, 4 and 10 count packages, Made in Malaysia, Distributed by Naturally Hard Supplements, Reno, NV --- UPC code #680474229116
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2018Historical recordClass I
UPROAR All Natural Male Enhancement Herbal Dietary Supplement Capsules, supplied in 2, 4 and 10 count packages, Distributed by AH Distribution, DelRay, Beach, FL ---- UPC Code 680474229260
by Organic Herbal Supply
- Reason
- Marketed without an Approved NDA/ANDA; FDA analysis found the presence of undeclared tadalafil, sildenafil and/or their analogues and Flibanserin
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 29, 2018Historical recordClass I
Paliperidone Extended-Release Tablets, 3 mg, 90 count bottles, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, NDC: 0591-3693-19
by Teva Pharmaceuticals
- Reason
- Failed Dissolution Specifications: Drug release test result, obtained during routine 9-month stability testing, which was below specification for one tablet. Teva cannot at this time exclude the potential for additional tablets to be below specification.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 15, 2022Historical recordClass I
EliquisTablets 5mg, 60 count bottle, Rx Only, Marketed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA and Pfizer Inc. New York, NY 10017 USA, NDC 0003-0894-21
by Bristol-Myers Squibb Company
- Reason
- Labeling: Label Mix-up: One bottle of Eliquis 5 mg tablet was found to contain lower-strength Eliquis 2.5 mg tablets only instead of the labeled 5 mg tablets.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 24, 2018Historical recordClass I
BRILINTA (ticagrelor) tablets, 90 mg, 8-count Professional Sample bottles, Rx only, Mfd. for: AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850; By: AstraZeneca AB, SE-151 85 Sodertalje, Sweden, NDC 0186-0777-08.
by AstraZeneca Pharmaceuticals, LP
- Reason
- Presence of Foriegn Tablets/Capsules: customer complaint that an 8-count professional sample bottle labeled as BRILINTA 90 mg tablets contained 5 ZURAMPIC 200 mg tablets, in addition to the expected 8 BRILINTA tablets.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: April 29, 2020Historical recordClass II
0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015; Distributed in Canada by Baxter Corporation, Toronto, Ontario, Canada, Product Code: 2B1322, NDC 0338-0049-02.
by Baxter Healthcare Corporation
- Reason
- Lack of Assurance of Sterility: Customer complaints for leaking bags.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2017Historical recordClass II
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 15 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-922-25
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2017Historical recordClass II
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 30 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-924-25
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2017Historical recordClass II
Potassium Phosphate (USP) QS 0.9% Sodium Chloride (USP) 250 mL 20 mmol in NS 250mL Bag, Advanced Pharma, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404. NDC15082-926-25
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: December 6, 2017Historical recordClass II
QUELICIN (Succinylcholine Chloride) Injection, USP 20 mg/mL in a) 5 mL vial (NDC 15082-814-67), b) 7mL vial (NDC 15082-814-79), c) 10mL vial (NDC 15082-814-61), Repackaged by Advanced Pharm, 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404.
by Advanced Pharma Inc.
- Reason
- Lack of Assurance of Sterility
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 7, 2017Historical recordClass II
NatureBox, Inc.
- Product
- NatureBox Mini Crispy Snickerdoodles: Cinnamon-sugar cookie…
- Reason
- One piece of a cashew was found during packing of Mini Crispy Snickerdoodle snack product.
- Published
- July 19, 2017
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 15, 2018Historical recordClass I
Wildway LLC
- Product
- Trader Joe's Grainless Granola 8 oz. (SKU 56307) packaged i…
- Reason
- Potential to be contaminated with Listeria monocytogenes.
- Published
- July 19, 2017
- 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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