Browse Drug Recalls
1,680 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,680 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 1,680 FDA drug recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 2, 2022 | Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam ... | Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of ... | Class III | HERON THERAPEUTICS, INC. |
| Jul 27, 2022 | Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx O... | Subpotent Drug | Class III | Amerisource Health Services LLC |
| Jul 22, 2022 | Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom... | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for... | Class III | Teva Pharmaceuticals USA Inc |
| Jul 20, 2022 | Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo... | Labeling: Label Error on Declared Strength | Class III | AVKARE Inc. |
| Jul 11, 2022 | Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Us... | Defective Container: Tube split from side seam | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jul 8, 2022 | Crest 3D White Fluoride Anticavity Toothpaste, Advanced Triple Whitening, 0.2... | Labeling: Missing label: the product tube was missing a label and contained a different formulation. | Class III | The Procter & Gamble Company |
| Jun 29, 2022 | Aspirin and Extended-Release Dipyridamole Capsules, 25mg/200 mg, 60-count bot... | Failed Tablet/Capsule Specification : Capsule breakage | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jun 29, 2022 | Juice Beauty, The Organic Solution, SPF 8, Naturally Clear Lip Moisturizer, H... | Failed Dissolution Specifications | Class III | Eco Lips, Inc |
| Jun 29, 2022 | Juice Beauty, The Organic Solution, SPF 8, Joyful Lip Moisturizer, Hydratant ... | Failed Dissolution Specifications | Class III | Eco Lips, Inc |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsul... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 21, 2022 | Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsu... | Superpotent Drug: Out of specification for assay at the 12-month timepoint. | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 16, 2022 | Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC ... | Defective Container | Class III | Glenmark Pharmaceuticals Inc., USA |
| Jun 3, 2022 | Olopatadine HCl, Ophthalmic Solution, USP, 0.2%, 2.5 mL per dropper bottle, R... | Failed impurity/degradation specifications: Out of specification for 2-HMP (a product leachable) ... | Class III | Akorn, Inc. |
| May 18, 2022 | Alprostadil Injection USP 500 mcg/mL, 1 mL Single Dose Vial, 5 vials per Cart... | Failed Impurities/Degradation Specifications; out-of-specification results for impurities obtaine... | Class III | Teva Pharmaceuticals USA Inc |
| May 13, 2022 | Tivicay (dolutegravir) Tablets 50 mg, 30-count Bottle, Rx Only, Manufactured ... | Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was print... | Class III | GlaxoSmithKline LLC |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Contai... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Con... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 10, 2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in ... | Failed Impurities/Degradation Specifications. | Class III | Novartis Pharmaceuticals Corporation |
| May 3, 2022 | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals), 100 mg, 100 Capsule... | Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at... | Class III | American Health Packaging |
| May 3, 2022 | Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apo... | Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded th... | Class III | Apotex Corp. |
| Apr 29, 2022 | Higher Education Make Out Ready Vegan Lip Balm, SPF 15, Net Wt. 0.15 oz (4.25... | Mislabeling: The active ingredient list on the label does not match the product's actual ingredie... | Class III | Eco Lips, Inc |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 29, 2022 | buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count b... | Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance foun... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Apr 27, 2022 | Open Nature Cough Drops Menthol-Cough Suppressant/Oral Anesthetic Peppermint ... | Subpotent drug: Low OOS for menthol content at the three month room temperature. | Class III | Bestco LLC |
| Apr 15, 2022 | Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2%, 100 mL per b... | Failed viscosity specification - product was below specificcation | Class III | Akorn, Inc. |
| Apr 14, 2022 | Phenobarbital Elixir, USP 20 mg/5 mL, 1 Pint (473 mL) bottles, Rx Only, Man... | Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content | Class III | Monarch PCM, LLC |
| Apr 13, 2022 | Ipratropium Bromide 0.5 mg and Albuterol Sulfate 3 mg Inhalation Solution 3mL... | cGMP deviations: Temperature abuse | Class III | Mckesson Medical-Surgical Inc. Corporate Office |
| Apr 12, 2022 | Cyanocobalamin Injection, USP, 1000 mcg per mL, For Intramuscular or Subcutan... | Subpotent Drug: Out of specification for assay. | Class III | American Health Packaging |
| Apr 5, 2022 | Cyanocobalamin Injection, USP, 1,000 mcg per mL, For IM or SC Use Only, 1 mL ... | Subpotent Drug: Out of Specification results for Assay | Class III | Aurobindo Pharma USA Inc. |
| Apr 1, 2022 | Methylprednisolone Tablets, USP 4mg, 100-count bottle, Rx Only, Manufactured ... | Subpotent | Class III | Jubilant Cadista Pharmaceuticals, Inc. |
| Apr 1, 2022 | 23.4% Sodium Chloride Injection, 120 mEq per 30 mL (4 mEq/mL), 50 mL prefille... | Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bro... | Class III | The Ritedose Corporation |
| Apr 1, 2022 | Cequa (cyclosporine ophthalmic solution) 0.09%, packaged in 6 pouches x 10 si... | Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for ... | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 29, 2022 | Wal-Tussin DM (dextromethorphan HBr/Guaifenesin), 12 FL OZ (354 mL) bottles, ... | Incorrect/Undeclared Excipient: Product contains alcohol | Class III | AptaPharma Inc. |
| Mar 18, 2022 | NETSPOT (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate... | Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability stud... | Class III | Advanced Accelerator Applications USA, Inc. |
| Mar 16, 2022 | Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Re... | Failed Impurities/Degradation Specifications: Out of Specification results for related substance. | Class III | Dr. Reddy's Laboratories, Inc. |
| Mar 10, 2022 | Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured... | FAILED CONTENT UNIFORMITY SPECIFICATIONS | Class III | Macleods Pharma Usa Inc |
| Mar 8, 2022 | Formula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atro... | Sub Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | SB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged... | Sub Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | Hydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% S... | Sub Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 8, 2022 | T-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) ... | Super Potent | Class III | Olympia Compounding Pharmacy dba Olympia Pharmacy |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... | Subpotent Drug | Class III | Fagron, Inc |
| Mar 4, 2022 | Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... | Subpotent Drug | Class III | Fagron, Inc |
| Feb 25, 2022 | Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... | Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... | Class III | Taro Pharmaceuticals U.S.A., Inc. |
| Feb 17, 2022 | Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... | Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... | Class III | Dr. Reddy's Laboratories, Inc. |
| Feb 14, 2022 | Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx ... | Subpotent drug | Class III | BayCare Integrated Service Center, LLC /dba Bay... |
| Jan 19, 2022 | Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Labo... | Failed stability specifications | Class III | Dr. Reddy's Laboratories, Inc. |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.