FDA Recall
Terminated
Historical recordClass II
Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
by Teligent Pharma, Inc.
- Reason
- Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
by Revive Rx LLC dba Revive Rx Pharmacy
- Reason
- Non-sterility; bacterial contamination identified as Paenibacillus lautus.
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
PARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01
by CooperSurgical, Inc
- Reason
- Non-sterility
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
by Celebrate Today
- Reason
- Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters packaged in a carton, ASIN B0847BSQQ5, Barcode X002G5GMJ1.
by Your Favorite Shop
- 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 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.
by SUN PHARMACEUTICAL INDUSTRIES INC
- Reason
- Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab Laboratories, Inc. Highland, NY 12528, Distributed by Par Pharmaceuticals, Chestnut Ridge, NY 10977, NDC 67253-660-10.
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 500-count bottles (NDC 67253-903-50), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 500-count bottles (NDC 67253-902-50), and c) 1000-count bottles (NDC 67253-902-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 500-count bottles (NDC 67253-901-50), and c) 1000-count bottles (NDC 67253-901-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) 500-count bottles (NDC 67253-900-50), and c) 1000-count bottles (NDC 67253-900-11), Rx only, Distributed by: Par Pharmaceutical Chestnut Ridge, NY 10977
by ANI Pharmaceuticals, Inc.
- Reason
- cGMP Deviations
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08Z63Z4QK, UPC 742137 605764.
by ABC Sales 1 Inc
- Reason
- Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
by ABC Sales 1 Inc
- Reason
- Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Moxifloxacin Ophthalmic Solution, USP 0.5% w/v, 3 mL bottle, Sterile, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ 08520, Made in India, NDC 65862-840-03
by Aurobindo Pharma USA Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- February 23, 2022
- Distribution
- Nationwide
View recall →
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 →
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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