Browse Drug Recalls
3,458 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 3,458 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 3,458 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 23, 2022 | AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/202... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Ready in case ACETAMINOPHEN PM CAPLETS 24 CT SKU 900559; TYLENOL CHILD GRAP... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAP... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | QP LAXATIVE BISACODYL 5 MG TABLET 50 CT SKU 902449 QP WOMEN LAXATIVE BISCOD... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ALKA SELTZER EXTRA STRENGTH 24 CT distributed to specific Family Dollar Store... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | AFRIN NO DRIP SEVERE CONGESTION 0.5FL OZ distributed to specific Family Dolla... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | READY IN CASE RUBBING ALCOHOL 91 PCT 16 FL OZ SKU 902270 READY IN CASE 70 ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar St... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | LIDOCAINE ARTHRITIS AND SPORT WNTGRN 16 FLOZ distributed to specific Family D... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Famil... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily s... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | READY IN CASE MICON 7 DAY 1.59 OZ SKU 939212 READY IN CASE MICON 3 DAY COMB... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | PEPCID COMPLETE CHEWABLE TAB BERRY 8CT SKU 903365 PEPCID AC MAXIMUM STRENGT... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | VOLTAREN ARTHRITIS PAIN GEL 20G distributed to specific Family Dollar Stores ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores ... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | READY IN CASE PAIN RELIEVER PM CAPLET 100 CT SKU 902381 GOOD SENSE PAIN REL... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Fa... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | DAYQUIL COLD FLU LQD 12 FL OZ SKU 900205 RIC NIGHT TIME CLD FLU RLF SOFT GE... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | ZARBEES NTRL CHLD COUGH MUCUS GRP 4 FL OZ distributed to specific Family Doll... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | FLEET GLYCERIN SUPPOSITORIES 50 CT distributed to specific Family Dollar Stor... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mou... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | REFENESEN MUCUS RELIEF TABLET 30 CT SKU 917531 MUCINEX DM MAX STRENGTH 7CT S... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 23, 2022 | BC POWDER 50 CT SKU 901588 BC POWDER 18 CT SKU 913228 GOODYS POWDER 50 CT... | CGMP Deviations: product held outside appropriate storage temperature conditions. | Class II | Family Dollar Stores, Llc. |
| Jun 21, 2022 | Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... | cGMP - Water leakage | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 10, 2022 | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 ... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Macleods Pharma Usa Inc |
| Jun 7, 2022 | MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 1... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cup... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cup... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 c... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dext... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 c... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL),... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cu... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 7, 2022 | Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per ... | CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... | Class II | Plastikon Healthcare LLC |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed a... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 6, 2022 | Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed a... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | PD-Rx Pharmaceuticals, Inc. |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose via... | CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 3, 2022 | Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... | CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rej... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 18, 2022 | Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Li... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 18, 2022 | Losartan Potassium Tablets, USP 25 mg, Rx only, Manufactured by: Vivimed Lif... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II | Strides Pharma Inc. |
| May 17, 2022 | AMBI Skincare Fade Cream Normal Skin, Net Wt. 2 OZ. (56g) | cGMP deviations: product stored outside of labeled temperature requirements. | Class II | Family Dollar Stores, Llc. |
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.