Drug Recall Records

This page shows recent human drug recall alerts sourced from the FDA. It includes current and some previously imported records, but is not a complete historical archive of all past recalls. For full historical data, visit the official FDA Drug Recalls page. Always consult a healthcare professional for medical advice.

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Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W.
Date: 08/15/2017
Product: Methylcobalamin 10mg, (10mg/ml), 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Company: Bella Pharmaceuticals, Inc.
Recall Reason: Lack of Assurance of Sterility.
Category: Class II
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L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon
Date: 08/15/2017
Product: L-Glutamine 100mg, 30 mL vials, Rx only, Bella Pharma 3101 W. Devon Ave., Chicago, IL 60659, 1 (877) BELLA.
Company: Bella Pharmaceuticals, Inc.
Recall Reason: Lack of Assurance of Sterility.
Category: Class II
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Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100
Date: 07/14/2017
Product: Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-171-12
Company: Cantrell Drug Company
Recall Reason: Lack of Sterility Assurance.
Category: Class II
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PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA
Date: 07/14/2017
Product: PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40
Company: SCA Pharmaceuticals
Recall Reason: Lack of Assurance of Sterility; product has the potential to leak.
Category: Class II
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Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5×10) Unit
Date: 06/19/2017
Product: Amantadine HCl Capsules, USP, 100 mg, Rx Only,  50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15
Company: Apace KY LLC
Recall Reason: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Category: Class II
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Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Date: 03/07/2017
Product: Zhonghua Niubian tablets, 2000mg, 6-count bottle, labeling is in foreign language
Company: A&H Focal Inc.
Recall Reason: Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall.
Category: Class I
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Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx Only,
Date: 02/22/2017
Product: Succinylcholine Chloride all strengths, all dosage forms and all packaging, Rx  Only, Avella of Houston, Houston, TX 77054
Company: Advanced Pharma Inc.
Recall Reason: Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
Category: Class II
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Alprostadil 20 mcg/mL Injectable, a) 5 mL and b) 10 mL vials,
Date: 09/21/2016
Product: Alprostadil 20 mcg/mL Injectable, a) 5 mL  and b) 10 mL vials, Compounded by Wells Pharmacy Network LLC, Ocala FL
Company: Wells Pharmacy Network LLC
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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M.I.C B-COMPLEX PREMIX W/HYDROXY B12 W/PRES. (BENZALKONIUM 0.01%) HYDROXY B12 1MG; B1
Date: 05/13/2016
Product: M.I.C B-COMPLEX PREMIX W/HYDROXY B12  W/PRES. (BENZALKONIUM 0.01%)  HYDROXY B12 1MG; B1 0.833MG; B2 0.083MG; B3 0.833MG,  B5 0.083MG, B6 0.083MG, CYANO B12 1.66MCG,  METHIONINE 0.208MG, INOSITOL 0.416MG, CHOLINE CL 1.66MG/ML, 10ML Vials, MEDAUS PHARMACY
Company: Medaus, Inc.
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%) METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In
Date: 05/13/2016
Product: M.I.C 25/50/50 W/PRES. (BENZYL ETOH 2%)  METHIONINE 25MG;INOSITOL 50MG;CHOLINE CHL 50/MG/ML, In a) 5ML Vials and b) 10ML Vials, MEDAUS PHARMACY
Company: Medaus, Inc.
Recall Reason: Lack of Assurance of Sterility
Category: Class II
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2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9%
Date: 05/05/2016
Product: 2 mcg/mL Fentanyl Citrate and 0.16% Bupivacaine HCl (Preservative Free) in 0.9% Sodium Chloride,	 100 mL in 150 mL Baxter Intravia Bag, Service Code 2K8102, Rx Only,  Compounded by PharMEDium Services, LLC, Memphis, TN 36141, NDC 61553-102-48
Company: Pharmedium Services, LLC
Recall Reason: Presence of Particulate Matter: API contaminated with glass particulate was used to produce sterile injectable drugs.
Category: Class II
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All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY,
Date: 03/25/2016
Product: All potassium bromide Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
Company: Reliable Rexall-A Compounding Pharmacy
Recall Reason: Lack of Processing Controls
Category: Class II
View Details View FDA Recall Listings
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