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
May 19, 2020 Doxycycline Hyclate Tablets, USP, 100 mg, 30 Tablets per carton (3 x 10), Rx ... Failed dissolution specification - dissolution results of 59% (spec. NLT 85%) at the 24 month tim... Class II American Health Packaging
May 19, 2020 LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Zilretta (triamcinolone acetonide extended-release injectable suspension), 32... Temperature Abuse: Product was stored at room temperature longer than 6 weeks and was inadvertent... Class III Flexion Therapeutics, Inc.
May 19, 2020 Maximum Strength Lidocaine Cold & Hot Patch (lidocaine 4%, menthol 1%), 5 pat... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 Mencaine (lidocaine 4.5%, menthol 5%) Patch, 1 patch per pouch, Manufactured ... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 19, 2020 LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches pe... CGMP Deviations: due to the loss of product manufacturing records and retain product samples, the... Class II Wuhan Bingbing Pharmaceutical Co., Ltd.
May 15, 2020 Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... Failed dissolution specifications Class II PD-Rx Pharmaceuticals, Inc.
May 15, 2020 EcoLips Sport Lip Balm, SPF 30, Avobenzone (5%), Octinoxate (10%), Octisalate... Superpotent Drug: The active ingredient, avobenzone, is used at 5% which is higher than the allow... Class II Eco Lips Inc
May 15, 2020 Estriol USP Micronized 5 G, Rx only, Triova 115 W 3rd Street Suite 720 Tulsa,... Failed impurities/ degradation specifications: Out of specification for organic impurities. Class II TRIOVA PHARMACEUTICALS LLC
May 14, 2020 Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: ... Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-ter... Class III InvaGen Pharmaceuticals, Inc.
May 13, 2020 Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. b... Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degra... Class III West-Ward Columbus Inc
May 13, 2020 Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC ... Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf l... Class II West-Ward Columbus Inc
May 11, 2020 Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... Failed Dissolution Specifications Class II Torrent Pharma Inc.
May 11, 2020 Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Curcumin, 4mg/mL, 10mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 11, 2020 Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... Class II BIOTA Biosciences LLC
May 8, 2020 LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira... Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matt... Class I ICU Medical Inc
May 5, 2020 Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only,... Discoloration: Out-of-specification results for appearance obtained during routine stability test... Class II Mylan Institutional LLC
May 5, 2020 Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, R... Short Fill Class III Exela Pharma Sciences LLC
Apr 24, 2020 Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine st... Class III The Harvard Drug Group
Apr 24, 2020 Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bott... Discoloration: product contains brown pellets Class III Dr. Reddy's Laboratories, Inc.
Apr 23, 2020 R.E.C.K. (Ropivacaine, Epinephrine, Clonidine, Ketorolac) in Sodium Chloride ... Presence of Particulate Matter: Fresenius Kabi recalling vials of Ketorolac Class III QuVa Pharma, Inc.
Apr 21, 2020 Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1... Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins Class II Sandoz, Inc
Apr 20, 2020 Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), package... Presence of Particulate Matter - found in reserve sample vials at the firm. Class II Fresenius Kabi USA, LLC
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: ... Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 se... Class II Lupin Pharmaceuticals Inc.
Apr 20, 2020 ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ... Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister... Class III Glaxosmithkline Consumer Healthcare Holdings
Apr 20, 2020 Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... Presence of Particulate Matter - found in reserve sample vials at the firm. Class I Fresenius Kabi USA, LLC
Apr 18, 2020 Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Pol... Class I B. Braun Medical Inc
Apr 15, 2020 Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin... Subpotent Drug: low out of specification (OOS) test result observed in long term stability study. Class II Lupin Pharmaceuticals Inc.
Apr 15, 2020 Acetaminophen and Codeine Phosphate 300/30 mg tablet, packaged in: a) 10-coun... cGMP Deviations Class II H J Harkins Company Inc dba Pharma Pac
Apr 15, 2020 KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By ... Chemical Contamination; product contains elevated levels of lead Class I Summitt Labs
Apr 15, 2020 Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Di... CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the ... Class II Amneal Pharmaceuticals of New York, LLC
Apr 14, 2020 Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Com... Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain m... Class I MasterPharm LLC
Apr 14, 2020 Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC... cGMP deviations: Presence of foreign material (Teflon)introduced at the production level. Class II B & B Pharmaceuticals, Inc.
Apr 6, 2020 Clobetasol Mouth Rinse 0.05% Solution 450 mL bottle, Rx, The Medicine Shoppe ... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Bi-Est (1:1)/Progesterone/Testosterone 2.0 mg/40 mg/1.0 mg/mL Cream 30 gm tub... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Naltrexone (Loxoral) 4.5 mg Capsules, 60 count bottle, Rx, The Medicine Shopp... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Bi-Est (1:1) Progest/Test 0.5 mg/40 mg/10.5 mg/mL Cream 30 gm tube, Rx, The M... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Bi-Est (8:2)/Progesterone 2/100 mg/mL capsule 90 caps bottle, Rx, The Medicin... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Testosterone W/Cosmetic HRT Base 100 MG (10%) Cream 30 GM, tubes Rx, The Medi... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Estriol Vaginal Cream (0.1%) 1 mg Cream 30 GM tubes, Rx, The Medicine Shoppe ... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Testosterone in Atrevis 50 mg/mL Gel 30 gm tube, Rx, The Medicine Shoppe Phar... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Bi-Est (50/50)/Progesterone 1.25 mg/80 mL Cream 30 gm tube, Rx, The Medicine ... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Hydrocortisone 2.5%/Econazole 1% 50/50 Using Powder 25%/1% Cream 60 gm tube, ... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Testosterone w/Cosmetic HRT Base 20 mg (2%) Cream 30 GM jar, Rx, The Medicine... Lack of Processing Control Class II The Medicine Shoppe Pharmacy
Apr 6, 2020 Bi-Est 8:2/Progesterone 2.5 mg/150/mL Cream 30 gm tube, Rx, The Medicine Shop... Lack of Processing Control Class II The Medicine Shoppe Pharmacy

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.