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Is Caffeine recalled?

51 FDA recalls mention Caffeine. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Caffeine.

Class III · Low risk Terminated Oct 13, 2021

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0075-2022

Class III · Low risk Terminated Oct 13, 2021

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0074-2022

Class III · Low risk Terminated Oct 13, 2021

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0073-2022

Class III · Low risk Terminated Oct 13, 2021

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0072-2022

Class III · Low risk Terminated Oct 13, 2021

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0071-2022

Class III · Low risk Terminated Oct 13, 2021

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case…

Reason Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compound Salicylic Acid.

Ultra Seal Corporation D-0070-2022

Class III · Low risk Terminated Aug 3, 2020

Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for…

Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Ultra Seal Corporation D-1513-2020

Class III · Low risk Terminated Aug 3, 2020

Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for…

Reason Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

Ultra Seal Corporation D-1512-2020

Class II · Moderate risk Terminated Apr 6, 2020

Ergotamine Tartrate 1 mg/Caffeine 100 mg base F Suppository (Pink) 48 suppositories, Rx, The Medicine Shoppe Pharmacy, Port…

Reason Lack of Processing Control

The Medicine Shoppe Pharmacy D-1226-2020

Class II · Moderate risk Terminated Apr 6, 2020

Ergotamine Tartrate 1 mg/Caffeine 100 mg Base Suppository (Pink) 48 count box, Rx, The Medicine Shoppe Pharmacy, Port Charlotte…

Reason Lack of Processing Control

The Medicine Shoppe Pharmacy D-1195-2020

Class II · Moderate risk Terminated Sep 10, 2018

Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02

Reason Lack of Assurance of Sterility

Pharm D Solutions, LLC NDC 69699-1428-02 D-0145-2019

Class I · High risk Terminated Jul 20, 2018

Dr. King's Natural Medicine Homeopathic Caffeine Detox, 2 fl. oz. (59 mL), King Bio, Inc., 3 Westside Dr. Asheville, NC 28806…

Reason Microbial contamination

King Bio Inc. NDC 57955-6202-2 D-0647-2019

Class II · Moderate risk Terminated May 22, 2017

Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (8.8 oz)., 1250 servings, Packed By: LifeLine…

Reason Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an unapproved drug due to stimulant claims. The…

Global Marketing Enterprises, Inc. D-1096-2017

Class II · Moderate risk Terminated Oct 6, 2015

CAFFEINE + SODIUM BENZOATE 500MG/ML, 35 mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake…

Reason Lack of Assurance of Sterility: all sterile compounded products within expiry

Chen Shwezin, Inc. dba Park Compounding Pharmacy D-0159-2016

Class II · Moderate risk Terminated Sep 22, 2015

Sedalmex (Acetaminophen 500 mg with Caffeine 65 mg) Pain Reliever tablets, 20-count tablets in blisters per box, Manufactured in…

Reason Cross Contamination With Other Products: Potential cross-contamination of cephalosporin.

Midway Importing, Inc D-0013-2016

Class II · Moderate risk Terminated Jul 2, 2013

ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603254421.

Reason Labeling: Label Mixup: ACETAMINOPHEN/ BUTALBITAL/ CAFFEINE, Tablet, 325 mg/50 mg/40 mg may have potentially been mislabeled as the following drug…

Aidapak Services, LLC D-982-2014

Class II · Moderate risk Terminated Jul 2, 2013

ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC…

Reason Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL…

Aidapak Services, LLC D-572-2014

Class II · Moderate risk Terminated Jul 2, 2013

CAFFEINE Tablet, 200 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 24385060173

Reason Labeling: Label Mixup; CAFFEINE Tablet, 200 mg may be potentially mislabeled as CALCIUM CITRATE, Tablet, 950 mg (200 mg ELEMENTAL Ca), NDC…

Aidapak Services, LLC D-540-2014

Class II · Moderate risk Terminated Jul 2, 2013

ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC…

Reason Labeling: Label Mixup; ACETAMINOPHEN/ ASPIRIN/ CAFFEINE, Tablet, 250 mg/250 mg/65 mg may be potentially mislabeled as NAPROXEN, Tablet, 500 mg…

Aidapak Services, LLC D-476-2014

Class II · Moderate risk Terminated Jun 6, 2013

Parsel Plus (reference US product: Excedrin Tension Headache) (Acetaminophen 500 mg and Caffeine 65 mg), packaged in 2-count…

Reason Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health D-846-2013

Class II · Moderate risk Terminated Jun 6, 2013

No Doz, Max Strength (200 mg caffeine) caplets, 2-count caplets per pouch, Distributed by Novartis Consumer Health, Inc…

Reason Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health D-845-2013

Class II · Moderate risk Terminated Jun 6, 2013

Excedrin Migraine (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-count tablets packaged in pouches…

Reason Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health D-844-2013

Class II · Moderate risk Terminated Jun 6, 2013

Excedrin Extra Strength (Acetaminophen 250 mg, Aspirin (NSAID) 250 mg and Caffeine 65 mg), a) 2-ct tablets in pouches b) boxes…

Reason Defective container: products are packaged in pouches which may not have been fully sealed

Novartis Consumer Health D-843-2013

Class II · Moderate risk Terminated Jul 18, 2012

Walgreens ASPIRIN FREE TENSION HEADACHE, Pain Reliever/Pain Reliever Aid, Acetaminophen & Caffeine, 100 Coated Caplets, OTC ---…

Reason Incorrect/Undeclared Excipients: The firm recalled specific lots of Walgreens brand Aspirin Free Tension Headache Caplets due to the presence of…

LNK International, Inc. NDC 0363-0428-12 D-0319-2015

Class III · Low risk Terminated Apr 26, 2012

Midol Complete, Acetaminophen, Caffeine, Pyrilamine Maleate, Caplets, OTC, a) 16 ct. blister (NDC 0280-8005-16), b)24 ct…

Reason Labeling: Label Mix-up: This recall was initiated after identifying that the label statement on the blister strip regarding the maximum number of…

Bayer Healthcare, LLC NDC 0280-8005-16 D-1424-2012