Drug and pharmaceutical recalls
17624 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-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.
- 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
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