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.

2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0202-70
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b) 56-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Tagi Pharma, South Beloit, IL 61080; NDC 51224-0203-70
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: Sunrise Pharm., Rahway NJ, 07065; NDC 11534-0157-03
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Kvk-Tech, NDC 10702-0026-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm., LLC Newtown, PA 18940; NDC 69543-0409-11
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-0410-11) and b) 28-count bags (NDC 69543-0410-11), and c) 56-count bags (NDC 69543-0410-11) Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Virtus Pharm, LLC.
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, MFG: KVK-Tech, Newtown, PA 18940, NDC 0702-0077-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calvin Scott & Co., Inc. Alb., MN 87123, Mfg: Sun Pharm., Inc. Cranbury, NJ 08512, NDC 47335-0707-13
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, MN 87123, Manufactured by RLC, Cave Creek, AZ 85331 Labs, NDC 64727-3308-02
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs Cave Creek, AZ 85331, NDC 64727-3300-01
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by RLC Labs, Cave Creek, AZ 85331, NDC 64727-3300-02
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Manufactured by Accord Healthcare, Inc., Durham NC 27703; NDC 16729-0184-17
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123 Manufactured by Unichem Pharmaceuticals, NDC 29300-0128-10
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugCalvin Scott & Company, Inc.Class II
Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Albuquerque, NM 87123, Mfg: Accord Healthcare, Inc, Durham, NC 27703, NDC 16729-0183-17
CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent pouches.
2020-08-26FDA-DrugUltra Seal CorporationClass III
Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
2020-08-26FDA-DrugUltra Seal CorporationClass III
Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.
2020-08-26FDA-DrugCareFusion 213, LLCClass I
ChlroraPrep One-Step (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL Applicator - Clear, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-01
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
2020-08-26FDA-DrugCareFusion 213, LLCClass I
ChloraPrep With Tint (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) 3 mL applicators - Hi-Lite Orange 25 applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 054365-400-11
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
2020-08-26FDA-DrugCareFusion 213, LLCClass I
BD ChloraPrep Clear 3 mL Applicators (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA)) Sterile Solution, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Company, NDC 54365-400-32
Non-Sterility: Product is being recalled due to presence of Aspergillus Penicilloides
2020-08-26FDA-DrugLannett Company, Inc.Class II
Prednisone Tablets, USP 2.5 mg, 100 tablets, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, Manufactured by: Tianjin Tianyao Pharmaceuticals Co., Ltd No. 221 Huanghai Road, Tianjin Economical-Technological Development Area, Tianjin, China 300457 NDC 0527-2931-37
Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg
2020-08-26FDA-DrugSanofi-Aventis U.S. LLCClass II
Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75
Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.
2020-08-26FDA-DrugFerring Pharmaceuticals IncClass I
STIMATE (desmopressin acetate) Nasal Spray1.5 mg/mL, 2.5 mL glass vial with spray cap, Rx only, Manufactured for: CSL Behring LLC, King of Prussia, PA 19406-0901; By: Ferring GmbH, Kiel, Germany, NDC 0053-6871-00
Superpotent Drug
2020-08-26FDA-DrugFerring Pharmaceuticals IncClass I
Desmopressin Acetate Nasal Spray 10 mcg/0.1 mL, 5mL glass vial with spray cap, Rx only, Manufactured for: AMRING PHARMACEUTICALS INC., Berwyn, PA 19312, NDC 69918-501-05
Superpotent Drug
2020-08-26FDA-DrugFerring Pharmaceuticals IncClass I
DDAVP Nasal Spray (desmopressin acetate) 10 mcg/0.1 mL, 5 mL bottles, Rx Only, Mfd for: Ferring Pharmaceuticals Inc., Parsippany, NJ 07054 USA, NDC 55566-2500-0
Superpotent Drug
2020-08-19FDA-DrugItech 361 LLCClass I
All Clean Hand Sanitizer, Fresh Scent, 1 Liter bottles, Ethyl Alcohol 70.00%, Produced by Eskbiochem SA de CV Ave Mexico Japon 50 Celaya, Gto. Mexico 38010, Distributed by All Clean Natural LTD, UPC Code 6 28055 37013 0
Chemical Contamination: Product contains undeclared methanol.
2020-08-19FDA-DrugLupin Pharmaceuticals Inc.Class II
Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC: 68180-911-13, Distributed by: Lupin Pharmaceuticals, Inc., MD, 21200, Manufactured by: Lupin Limited, India.
Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
2020-08-19FDA-DrugEosera, Inc.Class II
Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles/Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%), 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5
cGMP Deviations.
2020-08-19FDA-DrugEosera, Inc.Class II
Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0071-5, UPC 851722007125
cGMP Deviations.
2020-08-19FDA-DrugEosera, Inc.Class II
Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
cGMP Deviations.
2020-08-19FDA-DrugEosera, Inc.Class II
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
cGMP Deviations.

← prevpage 186/588next →

Get notified about new drug recalls

Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.

Get the Sunday Brief

Get notified about new drug recalls

Explore other recall topics