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FDA Drug Recalls

1,523 recalls · Class III, newest first

Class III · Low risk Terminated Oct 18, 2021

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only…

Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Macleods Pharma USA, INC NDC 33342-093-41 D-0079-2022

Class III · Low risk Terminated Oct 18, 2021

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC…

Reason Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.

Macleods Pharma USA, INC NDC 33342-088-45 D-0078-2022

Class III · Low risk Terminated Oct 13, 2021

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package…

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

Ultra Seal Corporation D-0077-2022

Class III · Low risk Terminated Oct 13, 2021

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package…

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

Ultra Seal Corporation D-0076-2022

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 Oct 12, 2021

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs…

Reason Failed Moisture Limits

Sun Pharmaceutical Industries INC NDC 63981-724-15 D-0069-2022

Class III · Low risk Terminated Oct 12, 2021

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg)…

Reason Failed Moisture Limits

Sun Pharmaceutical Industries INC NDC 0904-5833-15 D-0068-2022

Class III · Low risk Terminated Oct 5, 2021

Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg…

Reason Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it was a manufacturer in a box with 30 tablet count…

A-S Medication Solutions LLC. D-0096-2022

Class III · Low risk Terminated Sep 13, 2021

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505…

Reason Failed Impurities/Degradation Specifications; out of specification for Related Compound

Viatris NDC 0378-3231-93 D-0798-2021

Class III · Low risk Terminated Sep 3, 2021

Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631…

Reason Failed Impurities/Degradation Specifications

Meitheal Pharmaceuticals Inc NDC 71288-408-21 D-0801-2021

Class III · Low risk Terminated Sep 2, 2021

CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06…

Reason Subpotent Drug

New Vision Pharmaceuticals LLC NDC 69842-499-08 D-0853-2021

Class III · Low risk Terminated Sep 2, 2021

Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total/Nighttime Severe Cold &…

Reason Subpotent Drug

New Vision Pharmaceuticals LLC NDC 69842-495-16 D-0852-2021

Class III · Low risk Terminated Sep 1, 2021

Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, Rx only, Manufactured for: Westminster…

Reason Subpotency: one product for active ingredient assay and another one for preservative assay

Monarch PCM, LLC NDC 69367-174-01 D-0818-2021

Class III · Low risk Terminated Sep 1, 2021

Sodium 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…

Reason Subpotency: one product for active ingredient assay and another one for preservative assay

Monarch PCM, LLC NDC 42808-103-06 D-0817-2021

Class III · Low risk Terminated Aug 20, 2021

Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd. India, Marketed by: Jubilant…

Reason Subpotent

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-329-90 D-0784-2021

Class III · Low risk Terminated Aug 5, 2021

Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx only, Manufactured by Thymoorgan Pharmazie GmbH…

Reason Labeling: Not elsewhere classified: Mislabeling

Hikma Pharmaceuticals USA Inc. NDC 0143-9240-01 D-0771-2021

Class III · Low risk Terminated Aug 5, 2021

Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc…

Reason Out of specification results for conductivity.

DuPont Nutrition USA, Inc D-0728-2021

Class III · Low risk Terminated Jul 29, 2021

Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey…

Reason Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.

Teligent Pharma, Inc. NDC 52565-008-14 D-0785-2021

Class III · Low risk Terminated Jul 7, 2021

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by…

Reason Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say…

LNK International, Inc. NDC 46122-649-71 D-0665-2021

Class III · Low risk Terminated Jun 23, 2021

LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vials) per box, Rx only, Mfd by Partner Therapeutics…

Reason FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramostim) at the 27-month stability timepoint.

Partner Therapeutics Inc NDC 71837-5843-5 D-0655-2021