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.
- 2018-06-20FDA-DrugInopak LtdClass IIOption Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches, Inopak, LTD, Ringwood, NJ
Microbial contamination of NonSterile Product; FDA analysis returned out of specification results for total aerobic microbial counts
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIAcne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic acid) Shave Cream Acne Shield, one tube Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5% tube, and one Power Shaver per box, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos CA 90703 USA, UPC 7 80707 73114 7.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIAcne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL) tube, Distributed by: United Exchange Corp., 17311 Valley View Blvd, Cerritos, CA 90703 USA, UPC 7 80707 73111 6.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIAcne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) tube, Distributed by: United Exchange Corp., 17211 Valley View Blvd., Cerritos, CA 90703 USA, UPC 7 80707 73112 3.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugShadow Holdings DBA Bocchi LabsClass IIX-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
CGMP Deviations: products may be contaminated with bacteria.
- 2018-06-20FDA-DrugMedline Industries Inc (Northpoint Services)Class IIREADYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloths, 24-count flexible pack. Manufactured by Medline Industries, Inc. Mundelein, IL 60060 USA. NDC 53329-066-58.
Microbial Contamination of a Non-Sterile Product.
- 2018-06-20FDA-DrugPharMEDium Services, LLCClass IIHYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ
Superpotent and Subpotent
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz. (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street Brooklyn, NY 11204, NDC 57896-709-16, UPC 57896709167
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL OZ (473 mL) bottles, Dist by: Gericare Pharmaceuticals Corp. 1650 63rd Street, Brooklyn, NY 11204, NDC 57896-403-16, UPC 357896-403164,
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IISDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, Distributed by SDA Laboratories 280 Railroad Avenue, Greenwich CT 06830, NDC 66424-562-08, UPC 366424562082
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGeritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 mL) bottle, Distributed by Geritrex, LLC 144 Kingsbridge Rd East Mt Vernon, NY 10550, 1-800-736-3437, NDC 54162-007-08, UPC 354162007088
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIRitussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, Guaifenesin, USP 100mg), packaged in 4 FL.OZ. (118 mL), RIJ PHARMACEUTICAL CORPORATION 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 5380740904, UPC 35380740941
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 57696-452-08, UPC 357896452087
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIRPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottles, RIJ PHARMACEUTICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY, NDC 53807-129-16, UPC 353807129161
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIGericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged in 16 FL OZ (473 mL), Dist. By Gericare Pharmaceuticals 1650 63rd Street Brooklyn, NY 11204, NDC 5789618016, UPC 357896180164
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIRPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. OZ. (118 mL), RIJ PHARMACETUICAL CORPORATION, 40 COMMERCIAL AVENUE, MIDDLETOWN, NY 10941, NDC 53807-129-04, UPC 353807129048
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIRPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ Pharmaceuticals Corporation 40 Commercial Avenue, Middletown, NJ 10941, NDC 5380755608, UPC 353807556080
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIPreferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxide 200mg Simethicone 20mg, packaged in 12 FL. OZ. (355 mL) bottles, Manufactured By: RIJ PHARMACEUTICAL CORPORATION 40 Commercial Avenue Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357, NDC 53807-12612, UPC 53807126122
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-20FDA-DrugRIJ Pharmaceutical LLCClass IIPreferred Plus Pharmacy Antacid Extra Strength (Aluminum Hydroxide 400mg, Magnesium Hydroxide 400mg, Simethicone 40 mg), packaged in 12 FL. OZ. (355 mL), Manufactured By: RIJ Pharmaceutical Corp.40 Commercial Avenue, Middletown, NY 10941, Distributed by: Kinray Inc. Whitestone, NY 11357 NDC 53807-158-12, UPC 353807158123
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
- 2018-06-13FDA-DrugHOSPIRA INC, LAKE FORESTClass INaloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL
Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.
- 2018-06-13FDA-DrugJubilant Cadista Pharmaceuticals, Inc.Class IIIValsartan Tablets USP, 320 mg, 90 tablet, Rx Only, Manufactured by: Jubilant Generics Ltd. Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-363-90
Incorrect/Undeclared excipient: Product batches were released into commercial distribution with a larger size grade of excipient (Crospovidone).
- 2018-06-13FDA-DrugPharmaceutical Associates IncClass IIINystatin Oral Suspension, USP, 500,000 units/5 mL, For Institutional Use Only, packaged in 5 mL cups, Rx Only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-4810-05
Resuspension problems: Out of specification for appearance and resuspendability.
- 2018-06-13FDA-DrugApotex Inc.Class IIFluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1
Presence of foreign substance: glass particles
- 2018-06-06FDA-DrugShoreside Enterprises Inc.Class I7K capsules packaged in single packs sold in 24-count boxes, Distributed by SX Power Co. San Diego, CA 92108, UPC 601577513148
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- 2018-06-06FDA-DrugShoreside Enterprises Inc.Class IPOSEIDON Xtreme PLATINUM 4500,1000mg, packaged in single packs sold in 24-count boxes, Distributed by: Poseidon Distribution Atlanta, GA, UPC 638632428857
Marketed Without An Approved NDA/ANDA: FDA analysis found products to contain undeclared sildenafil and tadalafil. The presence of sildenafil and tadalafil makes these products an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- 2018-06-06FDA-DrugLUPIN SOMERSETClass IIIHydrocodone Bitartrate and Acetaminophen Tablets, USP, 5 mg/325 mg, 1000-count bottle Rx Only, Manufactured by: Novel Laboratories, Inc. Somerset NJ 08873 Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 212020 NDC 43386-356-10 UPC 343386356102
Labeling: Missing Label
- 2018-05-30FDA-DrugTeva Pharmaceuticals USAClass IIILidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
Failed Stability Specifications
- 2018-05-30FDA-DrugLupin Pharmaceuticals Inc.Class IIMy Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212 4.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
- 2018-05-30FDA-DrugLupin Pharmaceuticals Inc.Class IIMy Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulatory approval prior to release.
- 2018-05-30FDA-DrugIdeaz LlcClass IIscreamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g) tubes, UPC 7 50263 80062 5; b) 5 oz. (141g) tubes, UPC 7 50263 80006 9; and c) 16 oz. (454g) bottles, UPC 7 50263 80066 3; MFD FOR: Toast Products, 400 Sproul Street, Pittsburgh, PA 15136; NDC 52099-8010.
CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed in drug products.
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