FDA Recall
Ongoing
Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5552-3
by Noven Pharmaceuticals Inc
- Reason
- Defective Delivery System: Customer complaints received for ripping patches and tight release/adhesive transfer.
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
SnoreStop NasoSpray, 0.3 FL OZ (9 mL), Green Pharmaceuticals Inc. Camarillo, CA 93012, NDC 61152-199-99, UPC 7 69682 29101 3
by Green Pharmaceuticals, Inc.
- Reason
- Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
by Macleods Pharma Usa Inc
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-165-90 UPC 3 72789 16590 5
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-164-90 UPC 3 72789 16490 8
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed and Packaged By: PD-Rx Pharmaceuticals, Inc. Oklahoma City, OK 73127 Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 & 108 SIDCO Pharmaceutical Complex, Alathur, Kanchipuram-603 110, Tamilnadu, India NDC 72789-163-90 UPC 3 72789 16390 1
by PD-Rx Pharmaceuticals, Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wilton Industries Inc
- Product
- Wilton Rainbow Chip Crunch Sprinkles net wt 5.25 oz. item 71…
- Reason
- Milk contamination
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wilton Industries Inc
- Product
- Wilton Rainbow Sprinkles Mix net wt 5.92 oz. item number 71…
- Reason
- Milk contamination
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fudgeamentals LLC
- Product
- Fudgeamentals TIGER BUTTER FUDGE BAR (8 OZ)
- Reason
- made with peanut butter contaminated with Salmonella
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fudgeamentals LLC
- Product
- 1. Marketside FUDGE TRIO HOLIDAY FUDGE TRAY - 16 oz. 2. W…
- Reason
- made with peanut butter contaminated with Salmonella
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fudgeamentals LLC
- Product
- PEANUT BUTTER FUDGE BAR (24-8OZ) FUDGEAMENTALS
- Reason
- made with peanut butter contaminated with Salmonella
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fudgeamentals LLC
- Product
- PEANUT BUTTER FUDGE BITES (24-8 OZ) FUDGEAMENTALS
- Reason
- made with peanut butter contaminated with Salmonella
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fudgeamentals LLC
- Product
- PEANUT BUTTER CHOCOLATE FUDGE BITES (24-8 OZ) FUDGEAMENTALS
- Reason
- made with peanut butter contaminated with Salmonella
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fudgeamentals LLC
- Product
- VARIETY TRAY (16 OZ) (C-CNC-PBC) FUDGEAMENTALS
- Reason
- made with peanut butter contaminated with Salmonella
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Fudgeamentals LLC
- Product
- PEANUT BUTTER CHOCOLATE FUDGE BAR - 8 oz.
- Reason
- made with peanut butter contaminated with Salmonella
- Published
- July 6, 2022
- Distribution
- Nationwide
View recall →
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 →
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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