FDA Recall
🇺🇸 United States
TerminatedTerminated: August 7, 2025Historical recordClass I
New Age International, Inc.
- Product
- Daily Veggies Enoki Mushroom; Product of Korea; Net WT. 200…
- Reason
- Contaminated with Listeria monocytogenes
- Published
- March 26, 2025
- Distribution
- Distributed to wholesalers in NY that di…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 10, 2026Historical recordClass II
The Karma Sauce Company LLC
- Product
- HOT ONES brand ROJO, Los Calientes Hot Sauce, BY HEATONIST;…
- Reason
- Possible foreign object contamination (plastic).
- Published
- March 26, 2025
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: March 10, 2026Historical recordClass II
The Karma Sauce Company LLC
- Product
- HOT ONES brand VERDE, Los Calientes Hot Sauce, BY HEATONIST;…
- Reason
- Possible foreign object contamination (plastic).
- Published
- March 26, 2025
- Distribution
- Multiple states
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 9, 2026Historical recordClass II
Great Lakes Cheese Co Inc
- Product
- Happy Farms by ALDI Colby Jack (a blend of Colby & Monterey…
- Reason
- Potential foreign material (stainless steel fragments)
- Published
- March 26, 2025
- Distribution
- Distributors in four (4) states: CT, MI,…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 8, 2026Historical recordClass II
Trong Food International
- Product
- Madras Curry Powder sold in 3 different package sizes. Recal…
- Reason
- Elevated levels of lead 5.48mg/kg and 2.59mg/kg in (2) lots of Madras Curry Powder.
- Published
- March 26, 2025
- Distribution
- 3 distributor type customers. Two locate…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: April 22, 2025Historical recordClass I
NATURIPE VALUE ADDED FRESH LLC
- Product
- Berry Buddies; Blueberries, Mini Pancakes & Real Maple Syrup…
- Reason
- Incorrect back label on product resulting in undeclared allergens (wheat, eggs)
- Published
- March 26, 2025
- Distribution
- Distribution centers located in the foll…
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FDA Recall
OngoingHistorical recordClass II
Kids by babyganics SPF 50 mineral sunscreen totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%), packaged in 3 OZ spray bottles, Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403, UPC 813277019923 and UPC 813277019916
by Johnson, S C and Son, Inc
- Reason
- Chemical Contamination
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Kids by babyganics SPF 50 totally tropical (titanium dioxide 3/5%, zinc oxide 7.25%) packaged in a) 6 OZ (170 g) spray bottles UPC 813277019954 and UPC 813277019800; and b) Twinpack UPC 813277019930; Dist. by KAS Direct LLC, 1525 Howe St. Racine, WI 53403.
by Johnson, S C and Son, Inc
- Reason
- Chemical Contamination
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Walgreens, Acne Control Cleanser, 10% Benzoyl Peroxide/Acne Treatment, NET WT 5 OZ (142g) Distributed by: Walgreen CO, 200 Wilmont RD, Deerfield, IL, Made in Canada. UPC#: 1 9560203602 8
by Sigan Industries Group Inc.
- Reason
- Chemical Contamination: Presence of benzene
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Zapzyt, Acne Treatment Gel, 10% benzoyl peroxide Gel, packaged in 1 oz (28.35g) tube, Distributed by: FOCUS CONSUMER HEALTHCARE, LLC., 801 Broad St Ste 200, Chattanooga, TN 37402. NDC 71687-0011-1
by Denison Pharmaceuticals, LLC
- Reason
- Chemical Contamination: Presence of benzene.
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx Only, CAPS, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, 855-275-2270, NDC 71285-6092-1.
by Central Admixture Pharmacy Services, Inc.
- Reason
- Presence of Particulate Matter
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, 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
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Duloxetine Delayed-Release Capsules, USP, 60mg, Rx Only, 1000-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10
by Breckenridge Pharmaceutical, Inc.
- Reason
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
POTASSIUM CHLORIDE Inj., 10 mEq total in 100 mL, 100 mEq/L flexible container, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7074-26; Bar Code (01)00309907074269
by ICU Medical, Inc.
- Reason
- Labeling: Label Error on Declared Strength. Overwrap labeled as Potassium Chloride Inj 10 mEq may contain flexible containers of Potassium Chloride Inj 20 mEq
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass I
POTASSIUM CHLORIDE Inj., 20 mEq total in 100 mL flexible container 24 x case, 200 mEq/L, Rx Only, ICU Medical, Inc., Lake Forest, Illinois, 60045, USA, NDC# 0990-7075-26; Bar Code Flexible container (01) 00309907075266; Case (01)30309907075267
by ICU Medical, Inc.
- Reason
- Labeling: Label Error on Declared Strength. Cases labeled POTASSIUM CHLORIDE 20 mEq, may contain flexible containers with overwrap mislabeled as 10 mEq. The correct dosage strength of 20 mEq is printed on the labeling affixed to the product flexible container.
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Unisom, SleepMelts, Diphenhydramine HCl tablets, 25 mg, Nighttime Sleep-Aid, 4 x 8 blister packs per carton, Cherry flavor, Manufactured by Adare Pharmaceuticals, Inc., Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409, UPC # 0 41167 0014 0
by Chattem Inc
- Reason
- CGMP Deviations: Nitrosamine Drug Substance Related Issue impurity above the daily acceptable intake limit defined by the Food and Drug Administration.
- Published
- March 19, 2025
- Distribution
- Nationwide
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FDA Recall
OngoingHistorical recordClass II
Voriconazole Container Description: voriconazole The product packed in white poly bag containing black poly bag and tied each individual finally packed in HDPE container for shipping.
by Aspen Biopharma Labs Pvt., Ltd.
- Reason
- CGMP Deviations
- Published
- March 19, 2025
- Distribution
- Product was distributed to 3 distributor…
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FDA Recall
OngoingHistorical recordClass II
Latanoprost NDC# 82187-1002-1 Container Description: Amber colour bottle
by Aspen Biopharma Labs Pvt., Ltd.
- Reason
- CGMP Deviations
- Published
- March 19, 2025
- Distribution
- Product was distributed to 3 distributor…
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FDA Recall
OngoingHistorical recordClass II
Chlorambucil Container Description: The product packed in double self-seal cover and finally packed in Aluminum cover for shipping.
by Aspen Biopharma Labs Pvt., Ltd.
- Reason
- CGMP Deviations
- Published
- March 19, 2025
- Distribution
- Product was distributed to 3 distributor…
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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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