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.

2020-06-03FDA-DrugWuhan Bingbing Pharmaceutical Co., Ltd.Class II
LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
2020-06-03FDA-DrugWuhan Bingbing Pharmaceutical Co., Ltd.Class II
LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
2020-06-03FDA-DrugPD-Rx Pharmaceuticals, Inc.Class II
Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127
Failed dissolution specifications
2020-06-03FDA-DrugWest-Ward Columbus IncClass II
Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
2020-05-27FDA-DrugWest-Ward Columbus IncClass III
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
2020-05-27FDA-DrugInvaGen Pharmaceuticals, Inc.Class III
Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
2020-05-27FDA-DrugMylan Institutional LLCClass II
Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
2020-05-27FDA-DrugICU Medical IncClass I
LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
2020-05-20FDA-DrugMasterPharm LLCClass I
Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.
Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
2020-05-20FDA-DrugGlaxosmithkline Consumer Healthcare HoldingsClass III
ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
2020-05-20FDA-DrugGlaxosmithkline Consumer Healthcare HoldingsClass III
ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
2020-05-20FDA-DrugGlaxosmithkline Consumer Healthcare HoldingsClass III
ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
2020-05-20FDA-DrugThe Harvard Drug GroupClass III
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
2020-05-13FDA-DrugTeva Pharmaceuticals USAClass II
Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
2020-05-13FDA-DrugSandoz, IncClass II
Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
2020-05-06FDA-DrugB. Braun Medical IncClass I
Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
2020-05-06FDA-DrugDr. Reddy's Laboratories, Inc.Class III
Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10
Discoloration: product contains brown pellets
2020-05-06FDA-DrugAmneal Pharmaceuticals of New York, LLCClass II
Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
2020-04-29FDA-DrugLupin Pharmaceuticals Inc.Class II
Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
2020-04-29FDA-DrugYusef Manufacturing Laboratories, LLCClass II
PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline.
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
2020-04-29FDA-DrugLupin Pharmaceuticals Inc.Class II
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
2020-04-29FDA-DrugNoven Therapeutics, LLCClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
Defective Delivery System: Out of specification for mechanical peel and shear.
2020-04-29FDA-DrugNoven Therapeutics, LLCClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
Defective Delivery System: Out of specification for mechanical peel and shear.
2020-04-29FDA-DrugNoven Therapeutics, LLCClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3
Defective Delivery System: Out of specification for mechanical peel and shear.
2020-04-22FDA-DrugH J Harkins Company Inc dba Pharma PacClass II
Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-count bottle (NDC 52959-0003-10), b) 12-count bottle (NDC 52959-0003-12), c) 14-count bottle (NDC 52959-0003-14), d) 15-count bottle (NDC 52959-0003-15), e) 16-count bottle (NDC 52959-0003-16), f) 20-count bottle (NDC 52959-0003-20), g) 30-count bottle (NDC 52959-0003-30), h) 60-count bottle (NDC 52959-0003-60), Rx Only, Mfg. Aurobindo; Repack: H.J. Harkins Co., Inc., Grover Beach, CA 93433
cGMP Deviations
2020-04-22FDA-DrugB & B Pharmaceuticals, Inc.Class II
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
2020-04-22FDA-DrugFilltech USA, LLCClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
2020-04-22FDA-DrugFilltech USA, LLCClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
Microbial contamination of non-sterile products: positive test for yeast and bacteria.
2020-04-22FDA-DrugGolden State Medical Supply Inc.Class II
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
2020-04-22FDA-DrugAurobindo Pharma USA Inc.Class II
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed

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