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.
- 2021-09-29FDA-DrugMonarch PCM, LLCClass IIIHydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster Pharmaceuticals, LLC Nashville, TN 37217, NDC 69367-174-01 UPC 3 69367 17401 5
Subpotency: one product for active ingredient assay and another one for preservative assay
- 2021-09-29FDA-DrugMonarch PCM, LLCClass IIISodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC 42808-103-06 UPC 3 42808 10306 5; b) 12 fl oz (354.8 mL) NDC 42808-103-12 UPC 3 42808 10312 6, Rx only, Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
Subpotency: one product for active ingredient assay and another one for preservative assay
- 2021-09-29FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIValproic Acid Oral Solution USP, (250 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-621-16
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- 2021-09-29FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIPromethazine With Codeine Oral Solution, (Promethazine Hydrochloride 6.25 mg/5mL & Codeine Phosphate 10 mg/5 mL), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-606-16
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- 2021-09-29FDA-DrugMorton Grove Pharmaceuticals, Inc.Class IIPromethazine Syrup Plain, 6.25 mg/5 mL (Promethazine Hydrochloride Syrup, USP), 1 Pint (473 mL), Rx Only, Manufactured For: Wockhardt USA, LLC, Parsippany, NJ 07054; Manuractured By: Morton Grove Pharmaceuticals, Inc, Morton Grove, IL 60053. NDC: 60432-608-16
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
- 2021-09-29FDA-DrugAmerican Health PackagingClass IIISirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only, Packaged and Distributed by: American Health Packaging Columbus, OH 43217, NDC 68084-915-25
Failed Impurities/Degradation Specifications
- 2021-09-29FDA-DrugAurobindo Pharma USA Inc.Class IIMetoprolol Tartrate Tablets USP 100 mg, 1000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520, NDC 65862-064-99
Presence of Foreign Substance: Product complaints received for the presence of metal wire in one tablet.
- 2021-09-29FDA-DrugPfizer Inc.Class IIChantix (varenicline) tablets 1 mg, Carton containing 4 blister packs of 14 tablets each,, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-03. EXPIRATION DATE: September 2021 June 2023
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- 2021-09-29FDA-DrugPfizer Inc.Class IIChantix (varenicline) tablets 1 mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0469-56.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- 2021-09-29FDA-DrugPfizer Inc.Class IIChantix (varenicline) tablets 0.5mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 0069-0468-56.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- 2021-09-29FDA-DrugPfizer Inc.Class IIChantix (varenicline) tablets 0.5mg/1mg, 56 Tablets, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc. NY, NY 10017, Made in Ireland, NDC 00069-0471-03. carton containing one blister pack of 11 0.5 mg tablets and one blister pack containing 42.1 mg tablets.
CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim acceptable intake limit
- 2021-09-29FDA-DrugThe Harvard Drug GroupClass IICarbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152 USA. NDC 0904-6172-61
Failed Dissolution Specifications
- 2021-09-29FDA-DrugThe Harvard Drug GroupClass IIEntacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
Failed Dissolution Specifications
- 2021-09-22FDA-DrugICU Medical IncClass IAMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible containers, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7171-17
Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous material along with other particles, found in retain smples.
- 2021-09-22FDA-DrugPrescription Labs Inc dba GreenparkClass IISpironolactone Ophthalmic Solution 0.005 mg/mL, 15 mL bottles, Rx only, Greenpark Compounding Pharmacy
Lack of Assurance of Sterility
- 2021-09-22FDA-DrugPromise Pharmacy, LLCClass IIMIC+Methyl B12 injection Methionine Inositol Choline+Methylcobalamin 25 mg/50 mg/50 mg/1 mg/mL, 10 mL vial sterile, Rx only, Promise Pharmacy 31818 US Hwy 19N Palm Harbor FL 34684 1-888-3PROMIS
Lack of processing controls
- 2021-09-22FDA-DrugAkorn, Inc.Class IIBetamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701
Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.
- 2021-09-22FDA-DrugMeitheal Pharmaceuticals IncClass IIIGlycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21
Failed Impurities/Degradation Specifications
- 2021-09-22FDA-DrugTeligent Pharma, Inc.Class ILidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
Superpotent Drug
- 2021-09-22FDA-DrugVi-Jon, Inc.Class IIKroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Dist. By The Kroger Co., Cincinnati, Ohio 45202 NDC 30142-810-45, UPC 0 11110 37049
Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrect labeling.The primary label on the front and back label on some of the bottles have 70% Isopropyl Alcohol affixed to the containers. However, the product inside the bottle is Hydrogen Peroxide, Topical Solution USP with active ingredient Hydrogen Peroxide (stabilized) 3%, 32 FL Ounces
- 2021-09-22FDA-DrugViatrisClass IIICandesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93
Failed Impurities/Degradation Specifications; out of specification for Related Compound
- 2021-09-22FDA-DrugEbay Seller - John NguyenClass IHydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x 10 goi/sachets, MATXI CORP, UPC 8 936188 880108
Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine
- 2021-09-22FDA-DrugGrupo Asimex de Mexico SA de CVClass IIFlorance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
CGMP Deviations: All other lots are being recalled because they were manufactured under the same conditions as the product lots found to contain methanol.
- 2021-09-22FDA-DrugGrupo Asimex de Mexico SA de CVClass IFlorance Morris ANTISEPTIC Hand Sanitizer (ethyl alcohol 70%), packaged in a) 8.45 fl oz (250 mL) bottles and b) 33.81 fl oz (1L) bottles, Distributed by: Asimex International LLC, 9100 S Dadeland Blvd, Ste 912, Miami, FL 33156, COUNTRY OF ORIGIN: MEXICO.
Chemical Contamination: FDA analysis found the product contains methanol, additionally it is sub-potent for ethanol content.
- 2021-09-22FDA-DrugRhodes Pharmaceuticals, L.P.Class IIOxycodone Hydrochloride Tablets, USP, 10 mg, 100 count bottle, Rx only, Marketed by: Rhodes Pharmaceuticals L.P., Coventry RI 02816, Manufactured by: Purdue Pharma L.P., Stanford, CT 06901 NDC 42858-002-01
Presence of Foreign Tablets/Capsules; A single foreign tablet Hydrochlorothiazide/Lisinopril 25/20 was found in one bottle
- 2021-09-15FDA-DrugNATIVE PROMOTIONS, INCClass IIQiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, Manufactured by: Guangzhou Minghui Cosmetics Co., Ltd, Baiyun District, Guanzhou, China Distributed by Native Promotional Products, Tulsa, OK NDC 74447-010
Subpotent
- 2021-09-15FDA-DrugCharles Paint Research IncClass IIHAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
CGMP Deviations: Product contains acetaldehyde and acetal above the allowable limits.
- 2021-09-15FDA-DrugCharles Paint Research IncClass IIHAND SANITIZER (alcohol 80%), Alchol Antiseptic 80% topical solution, Hand Sanitizer non-sterile solution, Net weight (6 lbs 14.2 oz) 1 gallon; Net Quantity (3785 mL), Manufactured by Soapdaddy LLC, 2401 E. 85th Street, Kansas City, MO 64131
CGMP Deviations: Product manufactured in same facility where product was found to contain acetaldehyde and acetal above the allowable limits.
- 2021-09-08FDA-DrugChina Gel IncClass IIaulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
- 2021-09-08FDA-DrugChina Gel IncClass IICHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, packaged in a) 2 oz(56.8g) Tube, 76305-301-13 ; b) 4 oz (113.5 g) jar, UPC 6 87806 20004 1, NDC 76305-301-02 ; c) 6 OZ (170 g) tube, UPC 6 87806 20006 5, NDC 76305-301-03; d) 8 oz (226.8 g) Jar, UPC 6 87806 20008 9, NDC 76305-301-04; e) 16 oz ( 453.6 g) Bottle w/ Pump, UPC 6 87806 20016 4, NDC 76305-301-05; f) 120 oz (3.78L) gallon, UPC 6 87806 20128 4, NDC 76305-301-06: Distributed by: CHINA-GEL LLC, Arlington Heights, I
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
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