FDA Recall
Ongoing
Historical recordClass I
8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-5) and b) 25x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Carton NDC 51754-5001-4), For Intravenous Use Only, RX Only, Manufactured and Distributed by: Exela Pharma Sciences, LLC, Lenoir, NC 28645; ALSO LABELED 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), c) 20x50 mL Single Dose Vials, (Vial NDC 72572-740-01; Carton NDC 72572-740-20), Rx Only, Mfd for: Civica, Inc., Lehi, Utah, 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645.
by Exela Pharma Sciences LLC
- Reason
- Presence of Particulate Matter: Silicone
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for ITF Pharma, Inc., Berwyn, PA 19312 USA NDC:70726-0303-1 (carton) and 70726-0303-2 (bottle)
by ITF PHARMA INC
- Reason
- Failed Viscosity Specifications: Out-of-specification test results for viscosity
- Published
- November 29, 2023
- Distribution
- Distributed to one distributor in TN who…
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FDA Recall
Terminated
Historical recordClass III
Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 0615-8255-39), Rx only, Mfd By Lupin, PKG by Vangard Glasgow, KY 42141.
by NCS Healthcare of Kentucky Inc
- Reason
- Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card (NDC 0615-7718-39), Rx only, Mfd By Pliva HRVATSKA for Teva USA, PKG by Vangard Glasgow, KY 42141.
by NCS Healthcare of Kentucky Inc
- Reason
- Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass III
Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-count Bottle, NDC 68462-390-10: RX Only, Manufactured for: Glenmark, Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India,
by Glenmark Pharmaceuticals Inc., USA
- Reason
- Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass II
Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- drum. Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-052-03
by Integrity Bio-Chemicals LLC
- Reason
- CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
- Published
- November 29, 2023
- Distribution
- Distributed to one distributor in OK wit…
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FDA Recall
Terminated
Historical recordClass II
Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA, NDC: 77512-047-03
by Integrity Bio-Chemicals LLC
- Reason
- CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
- Published
- November 29, 2023
- Distribution
- Distributed to one distributor in OK wit…
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FDA Recall
Terminated
Historical recordClass II
Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) drum, Integrity Biochem, 1100 North Cresson Hwy, Cresson, TX 76035. Made in the USA NDC: 77512-044-03
by Integrity Bio-Chemicals LLC
- Reason
- CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
- Published
- November 29, 2023
- Distribution
- Distributed to one distributor in OK wit…
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FDA Recall
Terminated
Historical recordClass I
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1282-94
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
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FDA Recall
Terminated
Historical recordClass I
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 0536-1325-94.
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
- Published
- November 29, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass III
ActiPharma, Inc.
- Product
- ACTIRON Dietary Supplement, ActiPharma, 100 tablets (24 bott…
- Reason
- FDA sample analysis of ACTIRON Dietary Supplement, 100 Tablets, Lot 13309, found the product did not meet folic acid specification compared to the label claim.
- Published
- November 29, 2023
- Distribution
- Domestic distribution, in Puerto Rico.
View recall →
FDA Recall
Terminated
Historical recordClass II
Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Family Medical Supply, 2011 W Cumberland St. Dunn, NC 28334.
by Family Medical Supply Inc
- Reason
- cGMP Deviations
- Published
- November 22, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
by Omega & Delta Co., Inc.
- Reason
- Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
- Published
- November 22, 2023
- Distribution
- Distributed in Puerto Rico only.
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FDA Recall
Ongoing
Historical recordClass II
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00030 4
by Omega & Delta Co., Inc.
- Reason
- Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
- Published
- November 22, 2023
- Distribution
- Distributed in Puerto Rico only.
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FDA Recall
Ongoing
Historical recordClass II
DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico por: Omega & Delta Co., Inc. UPC 7 42699 00027 4
by Omega & Delta Co., Inc.
- Reason
- Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
- Published
- November 22, 2023
- Distribution
- Distributed in Puerto Rico only.
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FDA Recall
🇺🇸 United States
Terminated
Historical 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
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Tay's Sales and Distribution
- Product
- Full Spectrum Cold Pressed Hemp Oil Gummies, Fennel, 1.41 oz…
- Reason
- Sub-ingredients not declared for sunflower butter.
- Published
- November 22, 2023
- Distribution
- Direct to consumer and retail establishm…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Tay's Sales and Distribution
- Product
- Full Spectrum Cold Pressed Hemp Oil Gummies, Pomegranate, 1…
- Reason
- Sub-ingredients not declared for sunflower butter.
- Published
- November 22, 2023
- Distribution
- Direct to consumer and retail establishm…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Tay's Sales and Distribution
- Product
- Full Spectrum Cold Pressed Hemp Oil Gummies, Peach, 1.41 oz…
- Reason
- Sub-ingredients not declared for sunflower butter.
- Published
- November 22, 2023
- Distribution
- Direct to consumer and retail establishm…
View recall →
FDA Recall
🇺🇸 United States
Completed
Historical recordClass II
Tay's Sales and Distribution
- Product
- Full Spectrum Cold Pressed Hemp Oil Gummies, Blackberry, 1.4…
- Reason
- Sub-ingredients not declared for sunflower butter.
- Published
- November 22, 2023
- Distribution
- Direct to consumer and retail establishm…
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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