FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), 30 Patches (NDC 68968-5553-1) per box (NDC 68968-5553-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1.1 mg/hr), 30 Patches (NDC 68968-5552-1) per box (NDC 68968-5552-3), Rx only, Manufactured for Noven Therapeutics, LLC., Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186.
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: The number of customer complaints for ripping patches and tight release/adhesive transfer have exceeded the action limits.
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent Drug
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent Drug
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent Drug
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured by Alkem Laboratories Ltd, Mumbai, 400 013. INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054, NDC 67877-446-30.
by Ascend Laboratories LLC
- Reason
- Presence of Foreign Tablet/Capsule
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
SARA LEE FROZEN FOODS
- Product
- Sara Lee Pecan Pie 4oz. retail packaged UPC 032100051118, 24…
- Reason
- Potentially undeclared peanut
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brill Inc
- Product
- 10239710: 12" BAKED CHOCOLATE CHIP MESSAGE COOKIE 14 / 22 oz…
- Reason
- Potential to contain small foreign objects
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brill Inc
- Product
- 10233579 JUMBO CHOCOLATE CHIP COOKIE 12 / 12 INCH BAKED CHOC…
- Reason
- Potential to contain small foreign objects
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Brill Inc
- Product
- 10194739 TranSmart" 12 INCH CHOCOLATE CHIP MESSAGE COOKIE 24…
- Reason
- Potential to contain small foreign objects
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BREW DR KOMBUCHA LLC
- Product
- Brew Dr. Uplift Mango Passionfruit, Yerba Mate *Guayusa * Gr…
- Reason
- Yeast was found in shelf stable 16 oz. aluminum can of Brew Dr. Uplift drink.
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BREW DR KOMBUCHA LLC
- Product
- Brew Dr. Uplift Blood Orange Lemon, Yerba Mate *Guayusa * Gr…
- Reason
- Yeast was found in shelf stable 16 oz. aluminum can of Brew Dr. Uplift drink.
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
BREW DR KOMBUCHA LLC
- Product
- Brew Dr. Uplift Blueberry Raspberry Yerba Mate Guayusa, Gre…
- Reason
- Yeast was found in shelf stable 16 oz. aluminum can of Brew Dr. Uplift drink.
- Published
- June 2, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouches x 10 single-use vials (0.25 mL each)), Rx only, Manufactured for Sun Pharma Global FZE by: Laboratoire Unither, Coutances, France Distributed by Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 NDC 47335-506-96
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Subpotent and Presence of Particulates .
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep, 462 046, India, NDC 68180-405-01
by Lupin Pharmaceuticals Inc.
- Reason
- Subpotent Drug
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Delflex Peritoneal Dialysis Solution with 1.5% Dextrose, LM/LC, packaged in a case containing 2 x 6 Liter bags, Rx only, NDC 49230-206-60, Fresenius Medical Care North America, Waltham, MA 02451
by Fresenius Medical Care, North America
- Reason
- Labeling; Label Mix-up; 4.25% DEXTROSE bag was found inside a 1.5% DEXTROSE box.
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Thumbs Up 7 Blue 69K, 10 capsules, Distributed by Ummzy LLC., Made in USA, UPC 617135894673. Packaged in blister foil sheets in a box. Each box contains 10 capsules.
by Bit & Bet LLC
- Reason
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and tadalafil.
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein Sodium), 100 Sterile Strips (50 Pouches of 2 Strips Each), Manufactured by: Nomax, Inc, St. Louis, MO 63123, NDC: 51801-008-15
by Nomax Inc
- Reason
- Subpotent Drug
- Published
- May 26, 2021
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940 NDC 10702-055-03
by KVK-Tech, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- May 26, 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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