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FDA Drug Recalls

18043 recall notices on file. Class I recalls involve a reasonable probability of serious adverse health consequences or death.

ProductFirmClassificationStatusReport date
Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6820-76 Plastikon Healthcare LLC Class II Terminated 20220914
Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr. Suite 233, Livonia, MI 48152, NDC 0904-6739-71 Plastikon Healthcare LLC Class II Terminated 20220914
Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6738-70 Plastikon Healthcare LLC Class II Terminated 20220914
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73 Plastikon Healthcare LLC Class II Terminated 20220914
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73 Plastikon Healthcare LLC Class II Terminated 20220914
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72. Plastikon Healthcare LLC Class II Terminated 20220914
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73. Plastikon Healthcare LLC Class II Terminated 20220914
Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg MAX, per 30 mL Oral Suspension, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6839-73 Plastikon Healthcare LLC Class I Terminated 20220914
Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg per 30 mL, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6838-73 Plastikon Healthcare LLC Class I Terminated 20220914
MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6840-72. Plastikon Healthcare LLC Class I Terminated 20220914
MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0904-6846-73. Plastikon Healthcare LLC Class I Terminated 20220914
Triamcinolone Acetonide Cream USP, 0.1%, 80 g tube, Rx Only, Manufactured By Perrigo, Bronx, NY 10457, Distributed By Perrigo, Allegan, MI 49010, NDC 45802-064-36. Padagis US LLC Class II Terminated 20220907
Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ. (1 PT) 355 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965765. Tsm Brands LLC Class II Ongoing 20220907
Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734. Tsm Brands LLC Class II Ongoing 20220907
Neomycin Sulfate Tablets, USP 500 mg , 100-count bottles, Rx only, Distributed by: TEVA PHARMACEUTICALS USA, INC North Wales, PA 19454, NDC 0093-1177-01 Teva Pharmaceuticals USA Inc Class II Terminated 20220907
Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blisters per carton, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, UPC 0 50428 34873 4. LNK International, Inc. Class III Terminated 20220907
Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24 Akorn, Inc Class III Ongoing 20220907
Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 473 mL UPC 0 35000 67111 0. Dist. by: Colgate-Palmolive Co. New York, NY 10022 U.S.A. Family Dollar Stores, Llc. Class II Ongoing 20220907
Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT PASTE. Net Wt. 4.2 OZ. (119 g) UPC 0 35000 45836 0. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. Family Dollar Stores, Llc. Class II Ongoing 20220907
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT PASTE, Net Wt. 4.2 OZ. UPC 0 35000 97872 1. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. Family Dollar Stores, Llc. Class II Ongoing 20220907
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net Wt. 3.2 OZ. (90 g) UPC 0 35000 97159 3. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. Family Dollar Stores, Llc. Class II Ongoing 20220907
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITTE RENEWAL, 3% Hydrogen Peroxide, High Impact White, Net Wt. 3.0 OZ. (85 g) UPC 0 35000 97008 4. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. Family Dollar Stores, Llc. Class II Ongoing 20220907
Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevention, 5% Hydrogen Peroxide, Net Wt. 2.1 OZ. (59 g) UPC 0 35000 99658 9. Dist. by: Colgate-Palmolive Company New York, NY 10022 U.S.A. Family Dollar Stores, Llc. Class II Ongoing 20220907
Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%)128 Fl. Oz. (1 Gal.) 3.78 liters bottles, Southern Products & Services, Inc. 2515 Jake Drive Ste B, Cumming, GA 30028 Midlab Incorporated Class II Terminated 20220831
Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a) 1 U.S. Gallon (3.78 Liters) drums UPC 7 61841 02502 6 and b) 55 U.S. Gallon drums (208 Liters) UPC 0 07 61841 02504 0, Midlab 140 Private Brand Way, Athens, TN 37303 Midlab Incorporated Class II Terminated 20220831
VICKS DAYQUIL NYQUIL LIQ COMB PK 6 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
QP COUGH COLD TABLET 16 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
QP COLD MULTI SYMPTM DAY NITE CPLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT SKU 900854 RIC MUCUS RLF DM MAX STNGTH CHRY 6FL OZ SKU 999559 VICKS JARABE COUGH CONGESTION 8FLOZ SKU 998933 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
QP SUDFEDRINE PE MAX STRENGTH TBLT 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GELS 8 CT SKU 900523 ALKA SELTZER PLUS DAY NIGHT LGEL 20 CT SKU 902012 GS COLD FLU RELIEF NGHTTIME CHRY12FL OZ SKU 917523 RIC COLD FLU DAY TIME LIQUID CAP 16 CT SKU 903037 ASP SEVERE COLD COUGH CITRUS 20CT SKU 902906 ASP SEVERE COLD ORANGE ZEST 20CT SKU 902908 ALKA SELTZER PLUS SEVERE COLD ORIG 20CT SKU 903333 AS PLUS SINUS ALLERGY N COUGH PMAX 16CT SKU 903335 NYQUIL SEVERE VAPOCOOL LIQUID 8 FL OZ SKU 999542 AS PLUS MAX STRNGTH SINUS CONG N PN 20CT SKU 903334 GS DAYTIME COLD FLU RLF ORANGE 12FL OZ SKU 900576 NYQUIL SEVERE COLD FLU BERRY 8 FL OZ SKU 903759 NYQUIL ORGNL COLD AND FLU LQD 12FL OZ SKU 900207 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
ROBITUSSIN COUGH N CHEST CONGESTION 4 FL OZ SKU 919471 DELSYM ORANGE 3 FL OZ SKU 901880 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRAPE 4 FL OZ SKU 999368 GOOD SENSE ALLERGY CETIRIZINE 10 MG TABLET 14 CT SKU 916897 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
CLARITIN ALLERGY LIQ CHLDRNS GRAPE 2 FLOZ SKU 900834 CLARITIN ALLERGY 10MG TABLETS 5 CT SKU 916116 GS ALLERGY LORATADINE TABLET 30 CT SKU 916114 CLARITIN ALLERGY 10 MG TABLET 10 CT SKU 901655 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 MG 48 CT SKU 916003 QP ALLERGY MULTI SYMPTOM CAPLET 24CT SKU 916918 BENADRYL D CHILD ALLERGY SINUS GRAPE 4FO SKU 901738 GOOD SENSE CHILD ALLERGY CHERRY 4 FL OZ SKU 916917 BENADRYL ALLERGY CONGESTN ULTRA TAB 24CT SKU 999834 BENADRYL ALLERGY ULTRATAB 24CT SKU 902217 BENADRYL ALLERGY LIQUIDGELS 24 CT SKU 916715 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
GS ANTI DIARRHEAL LOPERAMIDE CAPLET 12 CT SKU 915632 IMODIUM AD MINT 4 OZ SKU 902080 IMODIUM AD CAPLET 6 CT SKU 915628 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STRENGTH 8 FL OZ SKU 914325 PEPTO BISMOL ORIGINAL 8 FL OZ SKU 914324 RIC BISMUTH REG STRENGTH CHERRY 8 FL OZ SKU 914781 PEPTO BISMOL CHERRY 8 FL OZ SKU 916063 PEPTO B LIQUID ORIGINAL TRAVEL 3.4 FL OZ SKU 999812 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
EXCEDRIN MIGRAINE CAPLET 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
NICORETTE GUM WHITE ICE MINT 4 MG 20 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
STYE EYE OINTMENT 0.125 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
NPX ENEMA 4.5 FL OZ 2 PK distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
MIDOL COMPLETE CAPLET 16 CT SKU 913028 QP MENSTRUAL RELIEF COMPLETE CAPLET 16CT SKU 999982 QP PMS FORMULA CAPLET 32 CT SKU 913232 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
CARMEX DAILY CARE CHERRY SPF 15 0.35 OZ SKU 901842 CARMEX LIP BALM JAR 0.25OZ SKU 903284 CARMEX STRWBRRY STCK W SPF 15 0.15OZ SKU 905760 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831