FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- CAPPUCCINO, Ice-cream base, natural flavoring, artificial fl…
- Reason
- Undeclared allergen: Milk.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- PINK GUABA, Ice-cream mix, filtered water, Natural Flavoring…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C red #6, red #5, yellow#5.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- BUTTER PECAN, Ice-cream base, Natural flavor, graham cracker…
- Reason
- Undeclared allergens: Milk and Tree Nuts. Undeclared color additives: FD&C yellow #5, blue #1, red #40, red#6, red #5.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- VANILLA, Ice-cream base, Natural flavor, artificial flavor a…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #6, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- GUAVA JELLY, Ice-cream base, natural flavoring, artificial c…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, yellow #8, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- MINT CHOCOLATE CHIP, Ice-cream base, Chocolate chips, Artifi…
- Reason
- Undeclared allergen: Milk. Undeclared color additives: FD&C yellow #5, blue #1, red #40.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Paradise Flavors LLC
- Product
- UNICORN Ice-cream base, natural flavors, Artificial Flavorin…
- Reason
- Undeclared allergen: Milk. Undeclared Color Additives: FD&C red #5, blue #1, red #3, red #40, yellow #5.
- Published
- November 22, 2023
- Distribution
- Domestic distribution only, within state…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: December 4, 2023Historical recordClass II
GIVE AND GO PREPARED FOODS CORP
- Product
- Item 19858, Amazon Fresh, Frosted Mini Brownie with yellow a…
- Reason
- Potential plastic pieces in the product.
- Published
- November 22, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 14, 2025Historical recordClass I
2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4903-11
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: identified as glass.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 14, 2025Historical recordClass I
1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Distributed by Hospira Inc., Lake Forest, IL 60045, NDC 0409-4904-11
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: identified as glass.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 14, 2025Historical recordClass I
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-5534-24
by Pfizer Inc.
- Reason
- Presence of Particulate Matter: identified as glass.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 12, 2024Historical recordClass III
V-FORCE Homeopathic, 1 FL OZ (30 ml) per glass bottle, Distributed by: BioActive Nutritional, Inc., 1803 N. Wickham Rd., Melbourne, FL 32935
by Grato Holdings, Inc.
- Reason
- Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).
- Published
- November 15, 2023
- Distribution
- Distributed to one direct account in Flo…
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FDA Recall
CompletedHistorical recordClass II
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass II
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
by Zydus Pharmaceuticals (USA) Inc
- Reason
- Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Deferasirox Tablets for Oral Suspension, 500mg, 30-count bottle, Rx only, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-496-30
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass III
Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg, 100 Tablets per bottle, Rx only, Distributed by: Zyla Life Sciences US Inc., Wayne, PA 19087. NDC: 69344-213-11
by Zyla Life Sciences US Inc.
- Reason
- Sub-potent Drug: Lower potency than labeled.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 21, 2025Historical recordClass III
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
by VistaPharm LLC
- Reason
- Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Ranolazine Extended-Release Tablets 500mg, 60 Tablets per bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur Dist - Dhar, Madhya Pradesh - 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-319-60.
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution.
- Published
- November 15, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 30, 2024Historical recordClass II
Clinical TREAT Antifungal Powder, Vanilla Scent, 3 OZ (85 g) tube, Active Ingredient: Miconazole Nitrate 2.0% w/w Antifungal, Manufactured for Medline Industries, LP, Three Lakes Drive, Northfield, IL 60093 USA, NDC: 53329-169-79
by MEDLINE INDUSTRIES, LP - Northfield
- Reason
- CGMP deviations: the product was shipped from the Manufacturer to a Medline warehouse and released to stock while it was still under investigation for low assay results on the active ingredient miconazole nitrate.
- Published
- November 15, 2023
- 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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