FDA Recall
Terminated
Historical recordClass III
Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512; Manufactured by: Sun Pharmaceutical Industries Ltd., Halol-Baroda HIghway, Halol-389 350 Gujarat, India, NDC 62756-142-02.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Moisture Limits: Out of specification for water content
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0
by Apotex Corp.
- Reason
- Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1
by Kimberly-Clark Corporation
- Reason
- Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
New Generation Wellness Inc.
- Product
- VEGAN VITAMIN D3, 50 mcg (2,000 IU), 60 VEGAN TABLETS in 100…
- Reason
- Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
New Generation Wellness Inc.
- Product
- Live Better vegan vitamin d-3 by CVS Health, 50 mcg (2000 IU…
- Reason
- Vitamin D3 stability sample analyzed and found to be less than 100% of label claim.
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Simply Delicious Inc.
- Product
- Bobo's Maple Pecan Oat Bars, 3 oz., UPC 8 2926200021 0, Best…
- Reason
- Two consumer complaints were received for peanuts in maple pecan bars.
- Published
- April 14, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.
by Ferring Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.
by Ferring Pharmaceuticals Inc
- Reason
- Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Crystallization: customer complaints for crystallization in finished product.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Crystallization: customer complaints for crystallization in finished product.
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Nuts.com
- Product
- Nuts.com brand Diced Dried Figs packaged in 1lb stand up gus…
- Reason
- Undeclared almonds in diced fig product
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Holiday Home Assorted Treat Toppings, 2.6oz (74g) 3 hanging…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Autumn Assorted Treat Toppings Sprinkles, 2.6oz (74g)…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Rainbow Chip Crunch Sprinkles, 5.25oz (148g) clear pl…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Holiday Mix Sprinkles, 7.6oz (215g) clear plastic bot…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Valentine Chip Crunch Sprinkles, 3.46 oz (98g) clear…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Wilton Industries Inc
- Product
- Wilton Rainbow Chip Crunch Sprinkles, 5.25 oz (148g) clear p…
- Reason
- Undeclared milk
- Published
- April 7, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09
by ICU Medical Inc
- Reason
- Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use
- Published
- March 31, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.
by Adams.Secret.co
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- March 31, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5
by Adams.Secret.co
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Published
- March 31, 2021
- 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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