FDA Recall
Terminated
Historical recordClass II
Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuticals USA Inc., North Wales, PA, 19454, NDC 0555-0808-02.
by Teva Pharmaceuticals USA Inc
- Reason
- Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Tablet/Capsule Specification; oversized tablet found in a bottle
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, 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 62756-015-40.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial excursion
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per carton, 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 62756-015-40.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rejected due to manufacturing issues that could cause the product to be out of specification for impurities.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) per Carton (51862-455-04), Rx only, Manufactured for: Mayne Pharma Greenville, NC 27834
by Mayne Pharma Inc
- Reason
- Defective Delivery System: Out of specification for release liner removal force results at the 3-month CRT stability timepoint.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in US with US and foreign components for Medline Industries, Inc., Mundelein, IL 60060 USA, NDC: 53329-798-04, UPC (01) 10888277362291.
by Vi-Jon, LLC
- Reason
- Defective Container: Product may leak when squeezed or when not in an upright position determined to be due to defects in the bottle neck finish and insufficient tightening.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EarthLab Inc
- Product
- Wise Woman Herbals Sleepytime Glycerite. Product is liquid a…
- Reason
- The microbial test result is found to be out of specification due to high yeast and mold counts.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EarthLab Inc
- Product
- Wise Woman Herbals Standardized Kava Glycerite, product is l…
- Reason
- The microbial test result is found to be out of specification due to high yeast and mold counts.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
EarthLab Inc
- Product
- Wise Woman Herbals Kava Capsules, 450 mg Kava (Piper met. Ro…
- Reason
- The microbial test result is found to be out of specification due to high yeast and mold counts.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Casper's Ice Cream, Inc
- Product
- Red Button Vintage Creamery Canadian Vanilla Ice Cream, 56 o…
- Reason
- Burnt Almond Fudge ice cream was packaged into Canadian Vanilla tubs during the run of the Burnt Almond Fudge. The Canadian Vanilla tubs do not list tree nut (almond) allergen in the ingredients list or contains statement leading to undeclared allergens.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Calico Cottage Inc
- Product
- 1. SALTED NUT ROLL PRE-MADE FUDGE (6SS) 6LB NET WT - not con…
- Reason
- Fudge contains peanut butter that is potentially contaminated with Salmonella.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Calico Cottage Inc
- Product
- 1. PEANUTTIEST CARAMEL CHOCOLATE P-MADE(6SS)6LB NT WT - not…
- Reason
- Fudge contains peanut butter that is potentially contaminated with Salmonella.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Calico Cottage Inc
- Product
- 1. PEANUT BUTTER FUDGE (3 - 6LB SLABS/CS) 18LB NET WT - not…
- Reason
- Fudge contains peanut butter that is potentially contaminated with Salmonella.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Calico Cottage Inc
- Product
- 1. PEANUT BUTTER CHOC (3 - 6LB SLABS/CS) 18LB NET WT - Not c…
- Reason
- Fudge contains peanut butter that is potentially contaminated with Salmonella.
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Albanese Confectionery Group, Inc.
- Product
- Rich s Milk Chocolate Giant Layered Peanut Butter and Cups R…
- Reason
- Salmonella. Product made using recalled Jif peanut butter
- Published
- June 29, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
JR Simplot Food Group
- Product
- Bulk, frozen french fries as Shoestring 1/4" Frozen Grade A…
- Reason
- Frozen french fries is being recalled due to undeclared wheat.
- Published
- June 29, 2022
- Distribution
- Product was distributed wholesale as a f…
View recall →
FDA Recall
Completed
Historical recordClass II
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottles labeled with UPC 7 501031 111190 and UPC 6 09002 40885, and b) 2 pack of 100-count bottles per carton UPC 3 72426 01434
by Walmart Inc
- Reason
- Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
- Published
- June 22, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bottles, UPC 7 501031 12705.
by Walmart Inc
- Reason
- Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labeling claims.
- Published
- June 22, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass I
Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, 100-count bottles, Melchor Ocampo No. 55 Local D, Delegacion Xochimilco, C.P. 16800, Mexico, D.F., UPC 7 501031 111190.
by Walmart Inc
- Reason
- Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory drug (NSAID) for the treatment of pain and inflammation.
- Published
- June 22, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specifications: Out of specification test results observed in dissolution testing during long term stability study.
- Published
- June 22, 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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