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  1. FDA Recalls
  2. ›Drug Recalls

FDA Drug Recalls

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

Classification
AllClass IClass IIClass III
Status
AllOngoingCompletedTerminated
Date
All timePast 30 daysPast 12 months

Showing 201–220 of 1,000 recalls

Class IIITerminated

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

Lupin Pharmaceuticals Inc.

Failed Stability Specifications: Out-of-specification results observed in a water loss test that might affect the assay content and alter drug concentration.

October 20, 2021 · DrugView details →
Class IIITerminated

Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA

MACLEODS PHARMA USA, INC

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

October 18, 2021 · Drug
View details →
Class IIITerminated

Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41

MACLEODS PHARMA USA, INC

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

October 18, 2021 · DrugView details →
Class IIITerminated

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41

MACLEODS PHARMA USA, INC

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

October 18, 2021 · DrugView details →
Class IIITerminated

Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shipping Label)

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

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

October 13, 2021 · DrugView details →
Class IIITerminated

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Moisture Limits

October 12, 2021 · DrugView details →
Class IIITerminated

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Moisture Limits

October 12, 2021 · DrugView details →
Class IIITerminated

Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S Medications Solutions, Libertyville, IL 60048, Mfg: Major Pharmaceuticals, Livonia, MI 48152, NDC: 50090-5510-3

A-S Medication Solutions LLC.

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

October 5, 2021 · DrugView details →
Class IIITerminated

Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-3231-93

Viatris

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

September 13, 2021 · DrugView details →
Class IIITerminated

Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, Mfd for Meitheal Pharmaceuticals, Chicago, IL 60631. NDC 71288-408-21

Meitheal Pharmaceuticals Inc

Failed Impurities/Degradation Specifications

September 3, 2021 · DrugView details →
Class IIITerminated

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 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895

New Vision Pharmaceuticals LLC

Subpotent Drug

September 2, 2021 · DrugView details →
Class IIITerminated

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 & Flu Relief 8 Pre-Measured Vials 1.01 FL OZ (30 mL) Each 8.12 FL OZ (240 mL) Total Single-Use Vials Mixed Berry Flavor NDC 69842-495-16 UPC 0 50428 64057 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895

New Vision Pharmaceuticals LLC

Subpotent Drug

September 2, 2021 · DrugView details →
Class IIITerminated

Hydroquinone, 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

Monarch PCM, LLC

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

September 1, 2021 · DrugView details →
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