FDA Recall
Terminated
Historical recordClass II
Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE and DROPPER, Rx Only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1768-36.
by Lannett Company, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out of specification results for related substances.
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE INTERNACIONAL
by Je Dois Lavoir LLC
- Reason
- Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sibutramine, a previously approved drug that was withdrawn from the US market due to safety concerns.
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
HARD DAWN, Rise and Shine capsules, 500 mg, packaged in 10-count blisters per carton, Made in Malaysia, UPC 680044 364926, ASIN: B077XCCL59
by Esupplementsales, LLC
- Reason
- Marketed Without an Approved NDA/ANDA: Firm was informed by Amazon that analytical testing showed the presence of tadalafil. Tadalafil is a FDA approved drug, making this product an unapproved drug.
- Published
- February 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters packaged in a carton, UPC 8 48998 00091 2, ASIN B08Z74KS88
by Junp Hydration LLC
- Reason
- Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- February 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10
by AuroMedics Pharma LLC
- Reason
- Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot
- Published
- February 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Siren Snacks
- Product
- Siren Birthday Cake Protein Bites, Item # 1104, brand Siren…
- Reason
- Undeclared cashews and almond butter allergens
- Published
- February 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CONAGRA BRANDS
- Product
- Wishbone Chunky Blue Cheese Dressing 24oz. bottle UPC 0-4132…
- Reason
- Undeclared eggs
- Published
- February 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
CONAGRA BRANDS
- Product
- Wishbone Thousand Island Dressing 15oz. bottle UPC 0-41321-0…
- Reason
- Undeclared eggs
- Published
- February 16, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mimvey (estradiol and norethindrone acetate tablets USP) 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx Only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-42
by Teva Pharmaceuticals USA
- Reason
- Mislabeling
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Mimvey (estradiol and norethindrone acetate tablets USP), 1 mg/0.5 mg, packaged in cartons of 28 Tablets, Rx only, Manufactured By: Barr Laboratories, Inc., Pomona, NY 10970, Manufactured For: Teva Pharmaceuticals USA Inc. North Wales, PA 19454, NDC 0093-5455-28
by Teva Pharmaceuticals USA
- Reason
- Mislabeling
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Tretinoin Capsules, 10 mg, 100 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0555-0808-02
by Teva Pharmaceuticals USA
- Reason
- Failed Dissolution Specifications; Low Out of specification (OOS) results for dissolution.
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sinus Relief Headache/Nasal (acetaminophen 325mg, phenylephrine HCl 5mg), 2 tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sinus Relief (acetaminophen 325mg, Guaifenesin 200mg, phenylephrine HCl 5mg), 2-tablet packets, Manufactured for Select Corporation, Carrollton, TX 75007
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
REMfresh Advanced Ion-Powered Melatonin (Melatonin 5 mg) Caplets, packaged in 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
REMfresh Advanced Ion-Powered Melatonin (Melatonin 2 mg) Caplets, packaged in a) 12-count blisters b) 36-count blisters Physician's Seal LLC, Boca Raton, FL 33487
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ELECTROLYTE Supplement Tablets (calcium 5.2 mg, Potassium 20.8 mg, Magnesium 6 mg ) 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MIRALAC (calcium carbonate 420mg) tablets, Mint Flavor, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
SINUS DECONGESTANT Nasal Decongestant (phenylephrine HCl 5mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
AYPANAL Non-aspirin Pain Reliever (acetaminophen 325 mg) tablets, 2-count packets, Dist. by Honeywell Safety Products USA, Smithfield, RI 02917
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124
by Ultra Seal Corporation
- Reason
- cGMP deviations
- Published
- February 9, 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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