Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-05-30FDA-DrugIdeaz LlcClass IIscreamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80072 4; b) 5 oz. (141g) tubes, UPC 7 50263 80007 6; and c) 16 oz. (454g) bottles, UPC 7 50263 80076 2; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8005.
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
- 2018-05-30FDA-DrugMilbar Laboratories, Inc.Class IIIZoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Subpotent
- 2018-05-30FDA-DrugMilbar Laboratories, Inc.Class IIIT Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.1 fl. oz. bottles, Dermatologic Cosmetic Laboratories, East Haven, CT
Subpotent
- 2018-05-30FDA-DrugMylan Pharmaceuticals Inc.Class IIPrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only, 48-count bottle, NDC 00378-4730-22
CGMP Deviations
- 2018-05-30FDA-DrugMylan Pharmaceuticals Inc.Class IIPrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, 48-count bottle, NDC 00378-4715-22
CGMP Deviations
- 2018-05-30FDA-DrugMylan Pharmaceuticals Inc.Class IIPrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 48-count bottle, NDC 00378-4710-22
CGMP Deviations
- 2018-05-30FDA-DrugFresenius Medical Care Renal Therapies Group, LLCClass II0.9% Sodium Chloride Injection, USP, 1000 mL, Rx Only, Fresenius Medical Care North America, Waltham, MA 02451, NDC 49230-0300-10.
Lack of Assurance of Sterility
- 2018-05-30FDA-DrugExela Pharma Sciences LLCClass IIDiclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-count bottle, Rx Only, Manufactured by: Cipla Ltd., India; For: EAGLE PHARMACEUTICALS, INC., Woodcliff Lake, NJ 07677 USA, NDC 42367-111-06.
Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg contained Diclofenac Sodium and Misoprostol 50 mg/0.2 mg tablets.
- 2018-05-30FDA-DrugMylan Pharmaceuticals Inc.Class IILoxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01
CGMP Deviations
- 2018-05-30FDA-DrugMylan Pharmaceuticals Inc.Class IILoxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01
CGMP Deviations
- 2018-05-30FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IILoxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- 2018-05-30FDA-DrugMylan Institutional, Inc. (d.b.a. UDL Laboratories)Class IILoxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-902-20
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
- 2018-05-30FDA-DrugAMA WholesaleClass IRhino 69 Extreme 50000 packaged in 1 capsule per blister pack, Distributed by AMA Wholesale Inc. Chino Hills, CA, 91709-2618, UPC Code: 718122071128
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared tadalafil. The presence of tadalafil makes Rhino Extreme 50000 an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- 2018-05-23FDA-DrugAuroMedics Pharma LLCClass IPiperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intravenous Use Only, Single-Dose vial, Rx Only, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ 05610. NDC 55150-120-30
Presence of Particulate Matter: confirmed customer report for presence of visible particulate matter, confirmed as glass
- 2018-05-23FDA-DrugApotex Inc.Class IPiperacillin and Tazobactam for Injection, USP 4.5 gram/vial* 10-count Single Use Vials per carton, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0688-4
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- 2018-05-23FDA-DrugApotex Inc.Class IPiperacillin and Tazobactam for Injection, USP 3.375 gram/vial* 10-count Single Use Vials per carton, Rx Only, Mfg. by: Hospira Healthcare India Pvt. Ltd. Irungattukottai-602 105, India Mfg. for: Apotex Corp. Weston, FL 33326. NDC 60505-0687-4
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
- 2018-05-23FDA-DrugMylan Pharmaceuticals Inc.Class IIAmlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6899-01
cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
- 2018-05-23FDA-DrugMylan Pharmaceuticals Inc.Class IIAmlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, Mylan Pharmaceuticals, Inc., Morgantown, WV --- NDC 0378-6896-01
cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
- 2018-05-23FDA-DrugSun Pharmaceutical Industries, Inc.Class IIIRiomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473 mL plastic bottle, Manufactured by: Mikart, Inc., Atlanta, GA 30318, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 10631-206-02
Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to identified labeling discrepancies in the patient literature.
- 2018-05-23FDA-DrugPerrigo New YorkClass IIHydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed by Perrigo, Allegan MI 49010, NDC 45802-014-02
Failed Stability Specifications
- 2018-05-23FDA-DrugL. Perrigo CompanyClass IIScopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 45802-580-84); b) 10-count (NDC 45802-580-46); c) 24-count (NDC 45802-580-62), Rx only, Mfd. by: Aveva Drug Delivery Systems, A Nitto Denko Company, Miramar, FL 33025 Distributed by Perrigo, Allegan, MI 49010
Defective delivery system
- 2018-05-23FDA-DrugPharmalucence, Inc.Class IIKit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 count), NDC 45567-0455-1 and (30 count), NDC 45567-0455-2 . Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.
Failed Stability Specifications
- 2018-05-23FDA-DrugMilbar Laboratories, Inc.Class IIMD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD Professional LLC, Minneapolis, MN
GMP Deviations
- 2018-05-23FDA-DrugMilbar Laboratories, Inc.Class IINaturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60mL bottles, Fortis BioPharma, Magnolia, TX 77354.
GMP Deviations
- 2018-05-23FDA-DrugMilbar Laboratories, Inc.Class IISolar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.5 FL OZ. 74 mL, Distributed by: BeautyRx LLC, NY, NY 10128
GMP Deviations
- 2018-05-23FDA-DrugMilbar Laboratories, Inc.Class IIB Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatologic Cosmetic Laboratories, East Haven, CT 06512 USA
Microbial Contamination of Non-sterile Product
- 2018-05-23FDA-DrugAidarex Pharmaceuticals LLCClass IIIFerrous Sulfate 325 MG tablet; NDC 33261-0715-00
Presence of Foreign Tablets/Capsules
- 2018-05-23FDA-DrugPrescript Pharmaceuticals, Inc.Class IIAcetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Mallinckrodt Inc. Hazelwood, MO 63042. Mnfct by:Mallinckrodt Inc. Hazelwood, MO 63042. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566 NDC: 00406-0484-10 Bar Code 0078-20-1834
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
- 2018-05-23FDA-DrugPrescript Pharmaceuticals, Inc.Class IIClindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct for: Lannett Co. Inc., Philadelphia, PA 19136. Mnfct. by: Lannett Co. Inc., Philadelphia, PA 19136. Pckgd by PreScript Pharm. Inc., Pleasanton, CA 94566. NDC: 00527-1383-01, Bar Code 0784-28-11
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
- 2018-05-23FDA-DrugPrescript Pharmaceuticals, Inc.Class IIChlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laboratories, Chicago, IL 60609. Mnfct by: pharmaceutical Assoiates, Inc., Greenville, SC 29605. Distrib by: PreScript Pharm. INC., Pleasanton, CA 94588. NDC: 00116-2001-16, Bar Code 1385-38-482
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
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