Browse Drug Recalls
1,091 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,091 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 1,091 FDA drug recalls in CA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2016 | papaverine prostaglandin 30 mg/30 mcg/mL, 5 mL unit size, refrigerate, This R... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine, 35 mg/2.5 mg/mL; 5 mL unit size; refrigerate,This... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 12/1 mg/9 mcg/mL; 5 mL and 10 mL unit... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Insulin, 70/30, 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Bupivacaine, 0.25%, 450 mL, This Rx is Compounded, Abbott's Compounding Pharm... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 30/1.5 mg/40 mcg/mL; 5 mL unit size, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 35/1.2 mg/20 mcg/mL; 10 mL unit size, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 30 mg/0.25 mg/10 mcg/mL; 10 mL unit si... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Folic Acid, 10 mg/mL, 6 mL unit size, refrigerate, This Rx is Compounded, Abb... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 35/1.5 mg/50 mcg/mL, 5 mL unit size, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 12/0.83 mg/10 mcg/ml; 5 mL and 10 mL u... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | methylcobalamine 10 mg/mL, 10 mL and 12 mL unit sizes, refrigerate, This Rx i... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Hydroxycobalamine 30 mg/mL, 90 mL unit size, refrigerate, This Rx is Compou... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | methylcobalamine 4 mg/mL, 5 mL and 30 mL unit sizes, refrigerate, This Rx is ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 12/1 mg/10 mcg/mL 5 mL and 10 mL unit... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 35/2 mg/40 mcg/mL, 10 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine 30 mg/1mg/mL, 5 mL and 10 mL unit size, refrigerate, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 30/2 mg/25 mcg/mL; 5 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/1 mg/30 mcg/mL; 10 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 12/1 mg/30 mcg/mL; 10 mL unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | methylcobalamine 1 mg/mL, 1 mL and 10 mL unit sizes, refrigerate, This Rx is ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 18/0.6 mg/6 mcg/mL; 10 mL unit size, ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/1.5 mg/15 mcg/mL; 10 mL unit size,... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | testosterone cypionate, 200 mg/mL, 6 mL and 10 mL unit sizes, This Rx is Comp... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 9/1 mg/10 mcg/mL, 10 mL, unit size, r... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/0.83 mg/20 mcg/mL; 5 mL and 10 mL ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Folic Acid, 5 mg/mL, 30 mL unit size, refrigerate, This Rx is Compounded, Abb... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | Licorice Coughing Liquid (guaifenesin), 5%, 3.38 fl. oz. (100 ml), OTC, Manuf... | Marketed Without An Approved NDA/ANDA: presence of undeclared morphine. | Class I | Master Herbs, Inc./Li |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 30/1 mg/10 mcg/mL; 5 mL, 7 mL and 10 ... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 35/2.5 mg/1 mcg/mL, 10 mL, unit size,... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phent, 25 mg/0.833 mg/mL, 20 mL unit size Refrigerate, This Rx is... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 22.5/0.83 mg/15 mcg/mL; 5 mL unit siz... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | hydroxyprogesterone in sesame 250 mg/mL, 2 mL, 5 mL, 6 mL, 8 mL unit sizes, T... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine prostaglandin 30 mg/20 mcg/mL, 10 mL unit size; refrigerate, This... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 17.16/0.57 mg/19.45 mcg/mL; 5 mLunit s... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | hydroxyprogesterone w/ pres; 1 mg/mL, 20 mL unit size, refrigerate, This Rx i... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Jan 15, 2016 | progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room tempe... | Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded produc... | Class II | Abbott's Compounding Pharmacy, Inc. |
| Dec 11, 2015 | FUEL UP HIGH OCTANE, capsules, a) 1-count package, b) 5-count bottle, c) 10-c... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... | Class I | Reesna, Inc |
| Dec 11, 2015 | FUEL UP PLUS, capsules, a) 1-count package, b) 5-count bottle, c) 10-count bo... | Marketed Without An Approved NDA/ANDA: Tainted Product Marketed As a Dietary Supplement: Products... | Class I | Reesna, Inc |
| Nov 25, 2015 | MECLIZINE HYDROCHLORIDE TABLETS, 12.5 mg, Packaged in 1000 ct Bottles, Rx Onl... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Golden State Medical Supply Inc. |
| Nov 25, 2015 | MECLIZINE HYDROCHLORIDE TABLETS, 25 mg, Packaged in a) 100 ct Bottles (NDC: 6... | Failed Impurities/Degradation Specifications: Out of specification for impurities. | Class III | Golden State Medical Supply Inc. |
| Oct 19, 2015 | HPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 19, 2015 | HPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL ... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 19, 2015 | HPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe,... | Failed pH Specification: It has been determined that the pH of the lots recalled, may not meet sp... | Class III | Oasis Medical, Inc. |
| Oct 7, 2015 | Nandrolone 200 mg/ml Injection, 10 mL and 20 mL vials, Rx, B & B Health Mart ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (30mg/50mcg/0.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (35mg/12mcg/1.5mg/ml), Injection, 10 mL vial, Rx, B & B Heal... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (30mg/40mcg/1mg/ml) Injection, 10 mL vial, Rx, B & B Health ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B Pharmacy |
| Oct 7, 2015 | PAPA/PGE1/PHENTO (15mg/5mcg/0.5mg/ml) Injection, 5 mL and 10 mL vials, Rx, B ... | Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting pr... | Class II | Pacific Healthcare, Inc dba B&B 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.