FDA Recall
Completed
Historical recordClass II
Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10
by Golden State Medical Supply Inc.
- Reason
- Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
by VistaPharm, Inc.
- Reason
- cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50.
by Ultra Chem Labs Corp
- Reason
- Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe)
by AuroMedics Pharma LLC
- Reason
- Subpotent Drug: Out of specification for assay
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Secrets Of The Tribe
- Product
- Indian Gooseberry Alcohol-Free Extract, 2 oz. glass bottle,…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Secrets Of The Tribe
- Product
- Amla Alcohol-Free Extract, 2 oz. glass bottle, UPC 041979376…
- Reason
- Product has elevated level of lead.
- Published
- November 2, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, USP - 900 mg, WATER FOR INJECTION, USP - qs, 1000mL Bag, 12 PK, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-300-10
by Fresenius Medical Care Holdings, Inc.
- Reason
- Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline Solution.
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORANT PHENYLEPHRINE HCl/ NASAL DECONGESTANT Maximum Strength Decongestant Free DISTRIBUTED BY: WALGREENS CO. 200 WILMOT RD., DEERFIELD, IL 60015 walgreens.com
by LNK International, Inc.
- Reason
- Boxes mislabeled to read "Decongestant Free", but the product contains Phenylephrine HCI 5mg
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Acyclovir Sodium Injection, 500mg/10mL (50mg/mL), 10 mL Single Dose Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520; Made in India, NDC 55150-154-10.
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: Customer complaint for a dark red, brown and black particulate floating inside vial.
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules, USP, 150 mg, 30-count bottle, Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA, NDC 51407-322-30
by Golden State Medical Supply Inc.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin Capsules, USP, 300 mg, packaged in a) 30-count bottle (NDC 51407-323-30), b) 60-count bottle (NDC 51407-323-60), c) 100-count bottle (NDC 51407-323-01), Rx only, Manufactured by Patheon Pharmaceuticals Inc., OH, Packaged by GSMS, Incorporated, CA.
by Golden State Medical Supply Inc.
- Reason
- Failed impurities/degradation specifications: Finished product exceeds the 5 ppm interim limit for 1-Methyl-4-Nitrosopoperazine (MNP).
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Flunisolide Nasal Solution, USP 0.025%, 25 mL bottles, Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC Orlando, FL 32839-6408; NDC 50742-317-25 UPC 3 50742 31725 7
by Ingenus Pharmaceuticals Llc
- Reason
- Out of specification for related substances (impurities).
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Seeking Health LLC
- Product
- Seeking Health brand Optimal Multivitamin Chewable Dietary S…
- Reason
- The product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper.
- Published
- October 26, 2022
- Distribution
- Distributed in AL, AK, AZ, AR, CA, CO, C…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
D. F. Stauffer Biscuit Co, Inc.
- Product
- White frosted animal cookies with multi-colored non-pareils…
- Reason
- Potential contamination with foreign material (metal).
- Published
- October 26, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Eden Foods, Inc
- Product
- Eden Organic Apple Juice in 32floz., 64floz., and 1.82L size…
- Reason
- culling not performed to remove rotted apples, excessive levels of patulin found in 1 lot
- Published
- October 19, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass III
Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter: Piece of metal found in a vial
- Published
- October 12, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dose Vials per pouch, NDC 69097-168-48; 60 (12 x 5) x 2 mL Sterile Unit-Dose Vials per carton, NDC 69097-168-64, Rx Only, Manufactured by: Cipla Ltd., Indore SEZ, Pithampur, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059.
by CIPLA
- Reason
- Lack of Assurance of Sterility: environmental monitoring failure.
- Published
- October 12, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass III
Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
- Published
- October 12, 2022
- 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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