FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), Manufactured In Canada By: TEVA CANA LIMITED, Toronto, Canada M1B 2K9; Manufactured For: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454. NDC: 0093-4161-73
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ALBUTEROL SULFATE IN 90MCG per actuation, 200 Metered Inhalations, Rx Only, 8.5 g Net Contents, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India. NDC: 68180-963-01
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
ALBUTEROL SULFATE HFA Inhalation Aerosol, 90MCG per actuation, 200 Metered Inhalations, Net Wt. 18 g, Rx Only, Manufactured for: Prasco Laboratories, Mason, OH 45040 USA. NDC: 66993-019-68
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 29, 2024Historical recordClass II
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL), 60 x 3 mL Sterile Unit-Dose Vials (2 pouches of 30 - 3 mL vials each), Manufactured By: The Ritedose Corporation, Columbia, SC 29203; Distributed By: Cipla USA Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-840-64
by CARDINAL HEALTHCARE
- Reason
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 12, 2024Historical recordClass III
ANORO ELLIPTA (umeclidinium and vilanterol inhalation powder) 62.5 mcg/25mcg. 1 inhaler contains 30 doses (60 blisters total), Rx Only, Manufactured by GlaxoSmithKline Durham, NC 27701. NDC 0173-0869-10
by GlaxoSmithKline LLC
- Reason
- Failed Release Testing: Coarse Particle Mass for umeclidinium Out of Specification
- Published
- January 3, 2024
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 18, 2024Historical recordClass I
Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aerosol cans (UPC 0 41388 0041 2, NDC 10157-4645-1) and b) 5.3 oz. aerosol cans (UPC 0 41388 00411 2, NDC 10157-4645-2) Blistex P.O. Box 5392, Oak Brook, IL 60522-5392.
by Blistex Inc
- Reason
- Chemical contamination: Presence of benzene
- Published
- December 27, 2023
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 10, 2024Historical recordClass I
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Reason
- Failed Content Uniformity Specifications
- Published
- December 27, 2023
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass I
TING 2% Miconazole Nitrate Athlete's Foot Spray Antifungal Spray Powder, NET WT 4.5 oz (128 g) cans, Distributed by: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare company, Tarrytown, NY 10591, UPC 363736532611.
by Insight Pharmaceuticals Corporation
- Reason
- Chemical Contamination; presence of benzene.
- Published
- December 27, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: June 28, 2024Historical recordClass I
Raw Seafoods Inc.
- Product
- Frozen, Lightly Seasoned Salmon Burgers, 28x6oz., 10.5 lbs c…
- Reason
- Contains undeclared sesame seeds and milk
- Published
- December 27, 2023
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 21, 2025Historical recordClass II
Liothyronine Sodium Tablets, USP 5 mcg, 100-count bottle, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. NDC 62756-589-88
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 20, 2023
- Distribution
- Nationwide
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FDA Recall
CompletedHistorical recordClass III
Votrient (pazopanib) 200 mg tablets, 120-count bottle, Rx Only, Manufactured by: Siegried Barbera, S.L., Barbera del Valles, Spain, Distributed by: Novartis Pharmaceuticals Corp., East Hanover, N.J. 07936, NDC 0078-1077-66
by Siegfried Barbera, SL
- Reason
- Failed Dissolution Specifications
- Published
- December 20, 2023
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: February 29, 2024Historical recordClass III
E.A. Sween Co.
- Product
- Deli Express, Deli Club 4.4oz wedge sandwich, 10 retail unit…
- Reason
- Label mix-up and therefore required label information is inaccurate
- Published
- December 20, 2023
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 25, 2024Historical recordClass I
Houdini Inc.
- Product
- Acorn Raspberry Creme Filled Cookie found in gift basket: #…
- Reason
- Undeclared allergens; tree nuts
- Published
- December 20, 2023
- Distribution
- U.S. distribution to the following: AK,…
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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