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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 3321–3340 of 17,723 recalls

Class IIOngoing

GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU914128 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

VASELINE ECZEMA CALMING THERPY CRM 6.8 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mouthwash 1 Liter SKU 902704 Swan Mouthwash Green Mint 1 LTR SKU 908114 Colgate Peroxyl Antiseptic Mouth Sore Rinse 8.4 FL OZ SKU 998273 Listerine Cool Mint Mouthwash 50.72 FL OZ SKU 999050 Swan Spring Mint Antiseptic Mouth Rinse 8.5 OZ SKU 900273 Swan Original Antiseptic Mouth Rinse 8.5 OZ SKU 900938 Colgate Optic White Mouthwash 16 FL OZ SKU 999043 Crest Scope Classic Original Min Mouthwash 1 Ltr SKU 908109 Listerine Cool Mint Mouthwash 500 mL SKU 908223 Act Kids Bubble Gum Blowout Mouthwash 16.9 Fl OZ SKU 999935 Swan Ice Mint Antiseptic Mouth Rinse 8.5 OZ SKU 903150 Swan Mouthwash Cool Mint 1 Liter SKU 908466 Crest Mouthwash Pro Health Multi Protection Mint 1 Liter SKU 908123, Colgate Mouthwash Total Advanced Peppermint Blast 1 Liter SKU 903156 Listerine Total Care Freshmine 1 Liter SKU 900980 Listerine Ultra Clean Cool Mint 1 Liter SKU 901904 Listerine Mouthwash Freshburst 1 Liter SKU 903159 Listerine Mouthwas Original Amber 1 Liter SKU 908004 Listerine Mouthwash Coolmint 1 Liter SKU 908005 Swan Antiseptic Rinse Amber 1 Liter SKU 908465 Crest Scope Mouthwash All Day 1 Liter SKU 998269 Listerine Mouthwash Coolmint 95 Milliliters SKU 999752 Swan Fresh Mint Mouthwash 1 Liter SKU 999762 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily skin 2 OZ SKU 2024222. distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

ALKA SELTZER EXTRA STRENGTH 24 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

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.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

SOFTSOAP ANTI BACTRIAL LQ SOAP 11.25 FLOZ SKU 2005090 DIAL LHS WHITE TEA AND VITAMIN E 7.5FLOZ SKU 2007700 SOFTSOAP LHS CC ANTIBAC ORANGE 50 FL OZ SKU 2007708 SPA SOAP ANTIBAC GLD LHS PUMP 20.2 FL OZ SKU 2097440 DIAL FOAMING LHS POWER BERRIES 7.5 FL OZ SKU 2044098 SOFTSOAP LIQUID HAND SOAP FERSH CITRUS AB 11.25 FL OZ SKU 2005088 SPA SOAP HNDSP ANTBCTRL ULTR2X GLD 64 FL OZ SKU 2008290 DIAL FOAMING LHS SPRING WATER 7.5 FL OZ SKU 2044177 DAWN ULTRA ANTIBAC APL BLOSSOM 21.6 FLOZ SKU 1498425 DAWN ULTRA APPLE 15.5 FL OZ SKU 1414227 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIOngoing

MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.

Family Dollar Stores, Llc.

CGMP Deviations: product held outside appropriate storage temperature conditions.

June 23, 2022 · DrugView details →

Class IIITerminated

Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-734-90.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

June 21, 2022 · DrugView details →

Class IITerminated

Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-dose vial, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceuticals Industries Ltd., Halol- Baroda Highway, Halol-Baroda, Highway, Halol- 389 350, Gujarat, India, NDC 62756-015-40.

SUN PHARMACEUTICAL INDUSTRIES INC

cGMP - Water leakage

June 21, 2022 · DrugView details →

Class IIITerminated

Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsules per bottle, Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 63304-735-90.

SUN PHARMACEUTICAL INDUSTRIES INC

Superpotent Drug: Out of specification for assay at the 12-month timepoint.

June 21, 2022 · DrugView details →

Class ITerminated

Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., NJ; Relabeled by: Bryant Ranch Prepack, Inc, CA, NDC 63629-1089-01

Bryant Ranch Prepack, Inc.

Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

June 17, 2022 · DrugView details →

Class ITerminated

Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx only, manufactured by: Ohm Laboratories Inc., New Brunswick NJ 08901 USA; Relabeled by: Bryant Ranch Prepack, Inc., Burbank, CA, 91504 USA, NDC: 63629-1088-01.

Bryant Ranch Prepack, Inc.

Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.

June 17, 2022 · DrugView details →

Class IITerminated

Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregate) 2.5 mg per vial, 30 glass vials per carton, Rx Only, Manufactured for Jubilant Draximage Inc. Kirkland, Canada, NDC 65174-270-30.

Jubilant Draximage Inc

Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing.

June 16, 2022 · DrugView details →

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