FDA Recall
Terminated
Historical recordClass III
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for Acela Pharmaceuticals, LLC Alphareta, GA 30005, NDC 42192-136-06
by Acella Pharmaceuticals, LLC
- Reason
- Subpotent drug
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 70518-3824-02; (a) 180-count blister pack, NDC 70518-3824-03; RX ONLY, MFG: Advagen Pharma Limited, Plainsboro. NJ 08536, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, 724.465.8762
by RemedyRePack Inc.
- Reason
- Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadol
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
traMADol Hydrochloride Tablets, USP 50 mg, 1000-count bottle, Rx Only, Distributed by: Advagen Pharma Limited, 666 Plainsboro Road Suite 605, Plainsboro, NJ, 08536, USA, Manufactured by: Rubicon Research, Private Limited, Ambernath, Dist. Thane, 421506 India NDC 72888-080-00
by Rubicon Research Private Limited
- Reason
- Presence of Foreign Tablets: Pharmacist reported a tablet of baclofen in a bottle of 1000-count tramadol
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Sub-potent Drug; powder discoloration associated with decreased potency
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass I
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
by Dr. Reddy's Laboratories, Inc.
- Reason
- Sub-potent Drug; powder discoloration associated with decreased potency
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60 mg, 90-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC: 51991-748-90.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 20 mg, , 500-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922, NDC 51991-746-05.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
Ongoing
Historical recordClass II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, (a) 90-count bottles (NDC 51991-747-90), (b) 1000-count bottles (NDC 51991-747-10), Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.
by Breckenridge Pharmaceutical, Inc
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Published
- May 15, 2024
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Belgian Yummies
- Product
- Belgian Yummies Homemade Ice Cream Horchata Gelato. Package…
- Reason
- Undeclared Allergen: milk and wheat.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Belgian Yummies
- Product
- Salted Caramel Ice Cream Cookie Sandwich. Sandwiches package…
- Reason
- Undeclared Allergen: milk, eggs, soy, wheat, peanuts, and tree nuts.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Belgian Yummies
- Product
- Raspberry Ice Cream Cookie Sandwich. Sandwiches packaged in…
- Reason
- Undeclared Allergen: milk,eggs, wheat, peanuts, and tree nuts.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Belgian Yummies
- Product
- Chocolate Ice Cream Cookie Sandwich. Sandwiches packaged in…
- Reason
- Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Belgian Yummies
- Product
- Belgian Yummies Homemade Ice Cream Birthday Cake Gelato. P…
- Reason
- Undeclared Allergen: Yellow #5
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Belgian Yummies
- Product
- Belgian Yummies Homemade Ice Cream Strawberry Gelato. Pack…
- Reason
- Undeclared Allergens: Yellow # 5
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
HTO Nevada Inc DBA Kirkman
- Product
- Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule diet…
- Reason
- Labeling error. The 5-MTHF 1mg label incorrectly declares 5000mcg Folic Acid instead 1000mcg Folic Acid per serving in the Supplement Facts, but correctly declares Folate 1667mcg DFE. The front label correctly declares product as 5-MTHF Methyltetrahydrofolate 1mg (or 1000mcg).
- Published
- May 15, 2024
- Distribution
- Distributed in CA, FL, OH, TX, WA and WI…
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FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Sacramento Cookie Factory
- Product
- Original Wine Wafer - Lemon Vanilla [Two sizes: retail packa…
- Reason
- Undeclared allergen (milk)
- Published
- May 15, 2024
- Distribution
- U.S. Distribution to the following state…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Sacramento Cookie Factory
- Product
- Tea Wafer - Vanilla Almond [Two sizes: retail package of 8 w…
- Reason
- Undeclared allergen (milk)
- Published
- May 15, 2024
- Distribution
- U.S. Distribution to the following state…
View recall →
FDA Recall
🇺🇸 United States
Ongoing
Historical recordClass II
Sacramento Cookie Factory
- Product
- Java Wafer - Mocha Hazelnut [Two sizes: retail package of 8…
- Reason
- Undeclared allergen (milk)
- Published
- May 15, 2024
- Distribution
- U.S. Distribution to the following state…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Belgian Yummies
- Product
- Peanut Butter Ice Cream Cookie Sandwich. Sandwiches packaged…
- Reason
- Undeclared Allergen: milk, eggs, wheat, peanuts, and tree nuts.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Belgian Yummies
- Product
- Key Lime Ice Cream Cookie Sandwich. Sandwiches packaged in a…
- Reason
- Undeclared Allergen: milk, eggs, soy, wheat, peanuts, and tree nuts.
- Published
- May 15, 2024
- Distribution
- The products were only distributed in th…
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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