Browse Drug Recalls

930 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 930 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 930 FDA drug recalls in 2020.

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DateProductReasonClassFirm
Aug 6, 2020 Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmac... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 m... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 6, 2020 Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy ... Lack of Assurance of Sterility Class II Family Pharmacy of Statesville
Aug 4, 2020 Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL ... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Command Brands GelAnti Bac Instant Hand Sanitizer, 70% Alcohol, , 8 FL OZ 250... CGMP Deviation: Potential contamination with undeclared methanol. Class II ROQUE PLAST, S.A. DE C.V.
Aug 4, 2020 Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor,... Subpotent drug: Out of specification for assay at the 15-month test interval. Class II PAI Holdings, LLC. dba Pharmaceutical Associate...
Aug 4, 2020 Day & Night Pack Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), 0.5 FL OZ (1... cGMP Deviations. Class II Eosera, Inc.
Aug 4, 2020 Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL) bottles, Eos... cGMP Deviations. Class II Eosera, Inc.
Aug 3, 2020 Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine ... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Aug 3, 2020 Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol ... Labeling Not Elsewhere Classified: Product labeled to contain methanol. Class II Leiper's Fork Distillery
Aug 3, 2020 Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65... Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compo... Class III Ultra Seal Corporation
Jul 31, 2020 Red Cross Oral Pain (Oral Anesthetic benzocaine 20%), Maximum Strength, 1/8 F... Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due ... Class III The Mentholatum Company
Jul 31, 2020 Jaloma Antiseptic Hand Sanitizer, Ethyl Alcohol 62% with Vitamin E, packaged ... cGMP deviations Class II Laboratorios Jaloma S.A. de C.V.
Jul 30, 2020 Hand Sanitizer (Alcohol 80% v/v) topical solution, 55 US GAL (208 L) EcoLab I... Discoloration and Presence of Foreign Substance Class II Ecolab Inc
Jul 30, 2020 Assured Instant Hand Sanitizer Vitamin E and Aloe (Ethyl Alcohol 70% v/v), 8 ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 NEXT ADVANCED ANTIBACTERIAL HAND SANITIZER (Ethyl Alcohol 70%), 8 FL OZ (236 ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 NuuxSan Instant ANTIBACTERIAL HAND SANITIZER, 70% Ethyl Alcohol (ethyl alcoho... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 Modesa INSTANT HAND SANITIZER with Moisturizers and Aloe Vera (ethyl alcohol ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 30, 2020 Assured Instant Hand Sanitizer Aloe & Moisturizers (Ethyl Alcohol 70% v/v) 8 ... CGMP Deviations: Next Advanced Antibacterial Hand Sanitizer was found to be below the label claim... Class II Albek De Mexico S.A. De C.V.
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Conta... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), ... Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint. Class II SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 2,500 units in 0.9% Sodium Chloride 500 mL, Single Dose Contai... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 29, 2020 Heparin Sodium 10,000 units in 0.9% Sodium Chloride 1000 mL, Single Dose Cont... Cross Contamination with Other Product(s): containers labeled as having methylparaben and propylp... Class I SCA Pharmaceuticals
Jul 27, 2020 Topiramate 25mg Tabs White/round tablets, 10-count bags, Distributed by: Calv... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phendimetrazine Brown/Clear Capsules, 105 mg, 28-count bags, Rx only, Distrib... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL White/Blue Speckled tablets, 37.5 mg, packaged in a) 7-count ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL White/Blue Speck Tabs 37.5 mg, 28-count bags, Rx only, Distri... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL Blue/White Capsules, 37.5 mg, 28-count bags, Rx only, Distri... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Thyroid 1 Grain Tablets, 28-count bags, Distributed by: Calvin Scott & Co., ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL GrayYellow capsules, 15mg, packaged in a) 28-count bags and b... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL Yellow Caps 30mg, packaged in 28-count bags, Rx only, Distrib... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Thyroid Neutral Tabs 2 gr, 28-count tablets, Rx only, Distributed by: Calvin ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL Gray/Yellow capsules, 15mg, 28-count bags, Rx only, Distribut... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Hydrochlorothiazide 50mg tablets, 14-count bags, Rx only, Distributed by: Cal... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... CGMP Deviations: products were recalled because they were manufactured in the same facility as th... Class II Broncolin, S.A. de C.V.
Jul 27, 2020 Hand Sanitizer Disinfectant Gel 70% Ethyl Alcohol, packaged in 6.7 FL Oz. (20... cGMP deviations Class II RESOURCE RECOVERY & TRADING LLC
Jul 27, 2020 HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, (Alcohol) 70%, packaged as ... Chemical Contamination: HERBACIL, Antiseptic Hand Sanitizer, 70% Alcohol, was found to be below ... Class I Broncolin, S.A. de C.V.
Jul 27, 2020 Hydrochlorothiazide (HCTZ) Orange Tabs 25mg, Distributed by: Calvin Scott & C... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine HCL Blue Speckled tablets, 37.5 mg, packaged in a) 14-count bags... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Thyroid 1 Gr tablets, 28-count bags, Rx Only, Distributed by: Calvin Scott & ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phendimetrazine Yellow Tabs 35mg, 28-count bags, Rx only, Distributed by: Cal... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phendimetrazine Yellow Tabs 35mg, packaged in a) 10-count bags (NDC 69543-041... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 HAND SANITIZER Non-sterile Solution 70% Topical Solution, packaged in 20L (5.... cGMP deviations Class II RESOURCE RECOVERY & TRADING LLC
Jul 27, 2020 Phentermine HCL Blue/Clear capsules, 30mg, packaged in a) 10-count bags (NDC ... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Hydrochlorothiazide 25mg tablets, Distributed by: Calvin Scott & Co., Inc. Al... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, Inc.
Jul 27, 2020 Phentermine 15mg grey/Yellow Capsules, 28-count bags, Rx only, Distributed by... CGMP Deviations: Light sensitive drug products repackaged in transparent/partially transparent po... Class II Calvin Scott & Company, 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.