Browse Drug Recalls
18,041 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 18,041 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 18,041 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 22, 2020 | NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles... | Superpotent Drug. | Class I | Acella Pharmaceuticals, LLC |
| 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 | 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 | 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 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 | 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 | 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 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 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 | Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC ... | Failed dissolution specifications | Class II | PD-Rx Pharmaceuticals, Inc. |
| 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 | 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 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 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 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 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 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 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 | Carbamazepine Tablets, USP 200 mg, packaged in a 500-count bottle, Rx only, M... | Failed Dissolution Specifications | Class II | Torrent Pharma Inc. |
| 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 | Potassium Acetate Injection, USP 40 mEq/20 mL (2 mEq/mL) Single Dose Vials, R... | Short Fill | Class III | Exela Pharma Sciences LLC |
| 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 |
| 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, 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 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 | 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 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 | 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 | 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 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 | 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 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 | 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 | 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 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 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 6, 2020 | Estradiol Vag Cream 0.01% Cream 30 gm tube, Rx, The Medicine Shoppe Pharmacy,... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Progesterone 200 mg Capsules 90 capsules, Rx, The Medicine Shoppe Pharmacy, P... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est8:2/Progesterone/Testosterone 1.0/50 MG/.5MG/ML Cream 30 GM tube, Rx, T... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (50/50)/Progesterone/Testost 1.5/100/0.5 mg Cream 30 gm tube, Rx, The ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Ketoprofen/DMSO 20%/10% Lipoderm 50 gm jar, Rx, The Medicine Shoppe Pharmacy,... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Estriol 5 mg Suppository 36 each box, Rx, The Medicine Shoppe Pharmacy, Port ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Testosterone w/ Atrevis 100 mg/mL GEL, 90 gm pump, Rx, The Medicine Shoppe Ph... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (1:1) Progest/Test 0.5 mg/1.5 mg/mL cream 60 gm tube, Rx, The Medicine... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Bi-Est (50/50)/Progesterone/Testosterone 1.5 mg/40 mg/0.5 mg/mL Cream 30 gm t... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Diethylstilbestrol 1 mg capsule 300 capsules bottle, Rx, The Medicine Shoppe ... | Lack of Processing Control | Class II | The Medicine Shoppe Pharmacy |
| Apr 6, 2020 | Naltrexone 4.5 mg/mL Suspension 30 mL bottle, Rx, The Medicine Shoppe Pharmac... | 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.