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.

2020-10-21FDA-DrugASHTEL STUDIOS, INC.Class I
Smart Care HAND SANITIZER, Ethyl Alcohol 62%, packaged in 0.84 FL.OZ (25 mL), labeled as a) Paw Patrol (Item #: 92321-144, UPC 8 50016 92321 9, NDC 70108-042-01); b) JoJo Siwa Dreamer (Item #: 92320-144, UPC 8 50016 92320 2, NDC 70108-044-01); c) Hot Wheels (Item #: 92317-144, UPC 8 50016 92317 2, NDC 70108-045-01); d) Barbie (Item #: 92318-144, UPC 8 50016 92318 9, NDC 70108-046-01); e) Trolls (Item #: 92322-144, UPC 8 50016 92322 6, NDC 70108-047-01); and f) Minions (Item #: 92319-144, UPC
Labeling: Not Elsewhere Classified. Container packaging is made, formed or filled to be misleading, resembling food and drink pouches
2020-10-21FDA-DrugLeadiant Biosciences, Inc.Class III
Cystaran (cysteamine ophthalmic solution) 0.44%, For Ophthalmic Use Only, 15 mL bottle, Sterile, Rx Only, Manufactured by Hi-Tech Pharmacal Co Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01
Subpotent Drug: Product testing identified a decreased level of the active ingredient, Cysteamine HCl.
2020-10-14FDA-DrugVistaPharm, Inc.Class III
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
2020-10-14FDA-DrugDirect RxClass II
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
2020-10-14FDA-DrugDirect RxClass II
Ranitidine 300 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-455-30
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-10-14FDA-DrugDirect RxClass II
Ranitidine 150 mg, a) 60 Tabs (NDC 61919-339-60); and b) 90 Tabs (NDC 61919-339-90) bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534
CGMP Deviations: Presence of NDMA impurity detected in product.
2020-10-14FDA-DrugPAI Holdings, LLC. dba Pharmaceutical Associates IncClass III
Citalopram Oral Solution, USP 20 mg/10 mL, 10 mL unit dose cups, Rx Only, Mfg for: Pharmaceutical Associates, Inc. Greenville, SC 29605 NDC 0121-1696-40
Failed Impurities/Degradation Specifications; high out of specification results obtained at the 9 month stability timepoint
2020-10-14FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine, 30 mg capsules, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-0597-10
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
2020-10-14FDA-DrugCalvin Scott & Company, Inc.Class II
Diethylpropion, 75 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1477-01
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
2020-10-14FDA-DrugCalvin Scott & Company, Inc.Class II
Diethylpropion, 25 mg tablets, Rx only, Distributed by: Calvin Scott & Co. Inc. Albuquerque, NM 87123; MFG. Lannett Company, Philadelphia, PA 19136, NDC 00527-1475-01
cMGP Deviations: Drug products repackaged into pouches without supporting stability studies.
2020-10-14FDA-DrugPD-Rx Pharmaceuticals, Inc.Class II
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
2020-10-07FDA-DrugAkorn, Inc.Class II
Eye Itch Relief, Ketotifen Fumarate Ophthalmic Solution 0.035%, Sterile, 5 mL, Distributed by CVS Pharmacy, Inc. Woonsocket, RI 02895, NDC 59779-920-01
CGMP Deviations
2020-10-07FDA-DrugpH-D Feminine HealthClass II
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
Marketed without an Approved NDA/ANDA.
2020-10-07FDA-DrugLegacy Pharmaceutical Packaging LLCClass III
Metformin Hydrochloride Tablets USP, 1000 mg, 60-count bottles, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc., East Brunswick, NJ 08816, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045, Distributed by: Wal-Mart, Bentonville, AR 72716. NDC 68645-545-59
Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
2020-10-07FDA-DrugArbor Pharmaceuticals Inc.Class III
Nymalize (nimodipine) oral solution, 60 mg/20 mL, 12 Unit-Dose Cups and 12 Oral Syringes, 2 inner cartons per outer shipping carton, Rx Only, Distributed by arbor Atlanta, GA, NDC 24338-200-12
Subpotent Drug
2020-10-07FDA-DrugVolu-Sol, Inc.Class I
Volu-Sol Handrub Sanitizing Solution (Ethyl Alcohol, 69% v/v and Isopropyl Alcohol, 7.2% v/v) Topical Solution, 473 mL/ 16 fl oz bottle, Vou-Sol 5095 W 2100 S, Salt Lake City, UT 84120, NDC 74401-800-16
Marketed Without an Approved NDA/ANDA: product lists methanol as an inactive ingredient on the label.
2020-10-07FDA-DrugDirect RxClass II
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
2020-10-07FDA-Drug4e Brands North America, LlcClass I
blumen ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT, (ethyl alcohol 70% v/v) Packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4, b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
2020-10-07FDA-Drug4e Brands North America, LlcClass I
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% natural boost with tea tree oil (70% ethyl alcohol), 33.8 fl oz / 1 L bottle, Distributed in USA and Canada by: 4e Brands 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico. UPC 8 14266 02374 7
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
2020-10-07FDA-Drug4e Brands North America, LlcClass I
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6 c) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3. Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
Chemical Contamination and Subpotent Drug: Product tested to contain methanol as well as below the labeled claim for ethanol content.
2020-10-07FDA-Drug4e Brands North America, LlcClass II
Modesa instant HAND SANITIZER with moisturizers & vitamin E, (70% ethyl alcohol), 33.8 FL OZ (1 L) bottle, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico. UPC 0 32251 49935 7
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
2020-10-07FDA-Drug4e Brands North America, LlcClass II
ASSURED Instant Hand Sanitizer Aloe & Moisturizers, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49070 4 b) 10 fL oz / 295 ml bottle, UPC 6 39277 49070 4, Distributed by Greenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
2020-10-07FDA-Drug4e Brands North America, LlcClass II
ASSURED Instant Hand Sanitizer Vitamin E and Aloe, (70% ethyl alcohol), Packaged as a) 8 fL oz / 236 ml bottle, UPC 6 39277 49069 8 b) 10 fL oz / 296 ml bottle, UPC 6 39277 49069 8, Distributed by Geenbrier International, Inc., 500 Volvo Parkway, Chesapeake, VA 23320, Made in Mexico
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
2020-10-07FDA-Drug4e Brands North America, LlcClass II
blumen Aloe ADVANCED HAND SANITIZER 70% ALCOHOL CONTENT (70% ethyl alcohol v/v), 3.4 fl. oz./100 mL bottle, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico. UPC 8 14266 02358 7
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
2020-10-07FDA-Drug4e Brands North America, LlcClass II
blumen Clear ADVANCED HAND SANITIZER with 70% ALCOHOL, (ethyl alcohol 70% v/v), Packaged as a) 2 fl oz / 60 ml bottle, UPC 8 14266 02371 6 b) 7.5 fl oz / 221 ml bottle, UPC 8 14266 02362 4 c) 15.2 fl oz (450 ml) bottle, UPC 8 14266 02392 1, d) 17 fl oz / 503 ml bottle with blue cap or pump bottle, UPC 8 14266 02409 6, e) 18 fl oz / 532 ml bottle, UPC 8 14266 02391 4, f) 33.8 fl oz / 1 L straight or curved bottle, UPC 8 14266 02369 3 g) 70 fl oz / 2.07L bottle, UPC 8 14266 02367 9 h) 1.05 GAL /
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
2020-10-07FDA-Drug4e Brands North America, LlcClass II
blumen ADVANCED HAND SANITIZER, 70% ALCOHOL CONTENT, (70% ethyl alcohol), packaged as a) 3.4 fl oz / 100 ml bottle, UPC 8 14266 02359 4 b) 7.5 fl. oz./221 ml bottle, UPC 8 14266 02362 4 b) 33.8 fl. oz./1L bottle, UPC 8 14266 02369 3, Distributed in USA and Canada By: 4e Brands Northamerica LLC, 17806 IH-10W, Suite 300, San Antonio, Texas, 78257, Made in Mexico.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
2020-10-07FDA-Drug4e Brands North America, LlcClass II
blumen ADVANCED INSTANT HAND SANITIZER Clear ETHYL ALCOHOL 70% Natural Boost with Tea Tree Oil, (70% ethyl alcohol), Packaged as a) 18 fl oz / 532 ml bottle, UPC 8 14266 02408 9 b) 33.8 fl oz / 1L bottle, UPC 8 14266 02374 7, Distributed in USA and Canada BY: 4e Brands Northamerica LLC. 17806 IH-10W, Suite 300, San Antonio, Texas, 78257. Made in Mexico.
CGMP Deviations: recalled because it was manufactured in the same facility as the product found to contain methanol which represents poor Current Good Manufacturing Practices.
2020-10-07FDA-DrugP & L Developments, LLCClass III
Nicotine Gum, Nicotine Polacrilex Gum USP, 2 mg (nicotine), 110-count pieces per carton, Distributed By: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-3328-3.
Labeling: Incorrect or Missing Package Insert: The package insert included in the finished product is for the Canadian market and is not part of the current approved drug labeling.
2020-10-07FDA-DrugTeva Pharmaceuticals USAClass II
Buprenorphine Transdermal System 5 mcg/hour, 4 transdermal systems/4 disposal units per carton, Rx Only, Manufactured by: 3M Drug Delivery Systems, 19901 Nordhoff street, Northridge, CA 91324 USA, Manufactured for: Teva Pharmaceuticals USA Inc., North Wales, PA 19454, carton NDC: 0093-3656-40, patch NDC: 0093-3656-21.
Failed Stability Specifications: Below specification result for buprenorphine release rate.
2020-10-07FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass II
RIOMET ER (metformin hydrochloride for extended-release oral suspension), 500 mg per 5 mL 16 oz. For Oral Use Only Rx Only Manufactured by: Sun Pharmaceuticals Industries Limited Mohali, India Distributed by: Sun Pharmaceuticals Industries, Inc. Cranbury, NJ 08512 NDC 10631-019-17
CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.

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