Browse Drug Recalls
86 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 86 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 86 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 26, 2013 | TRIPTROPIN PLUS INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE ONLY... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | B12/E2/E3/PROG/TEST 1/3.75/2.5/50/45 MG/ML OIL INJ SOLN, all presentations, F... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | COPPER 0.4MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY,... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | KETOROLAC TROMETHAMINE 60 MG/ML INJECTABLE, all presentations, FOR INTRAVENO... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | TRI-MIX 10 MCG/30 MG/1 MG/ML INJ SOLN and TRI-MIX 30 MCG/15 MG/2 MG/ML INJ SO... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | FREAMINE III ALT. 8.5% INJECTABLE, all presentations, FOR INTRAVENO AND SQ US... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | PROCAINE P/F 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | BUPRENORPHINE 0.1/0.05 MG/ML CREAM, all configurations, FOR INTRAVENO AND SQ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | ESTRADIOL VALERATE W/ LIDOCAINE 1% 40 MG/ML OIL INJ SOLN, all configurations,... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | PHOSPHATIDYLCHOLINE 50 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | NALBUPHINE HCL 20 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ U... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | PROGESTERONE 50 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND SQ U... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | DEXAMETHASONE SODIUM PHOSPHATE 10 MG/ML INJECTABLE, all presentations, FOR IN... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | BI-TROPIN S-2 INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | MULTITRACE-5 INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, ST... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | LIPO-PLEX INJECTABLE, all presentations, FOR INTRAVENO and SQ USE ONLY, STER... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | PROG/TEST CYP 15/7.5 MG/ML OIL INJ SOLN, all presentations, FOR INTRAVENO AND... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | LIDOCAINE MDV 1% INJECTABLE, LIDOCAINE MDV 20 MG/ML INJECTABLE and Lidocaine ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | CALCIUM EDTA 300 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | DMPS 50mg/ml INJECTABLE, all presentations, FOR INTRAVENO AND SQ USE ONLY, ST... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | METHYLPREDNISOLONE ACETATE 40 MG/ML and 80 MG/ML INJECTABLE, all presentatio... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | B-12/LIDOCAINE 25/10MG/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | CALCIUM CHLORIDE 100 MG/ML INJECTABLE, all presentations, FOR INTRAVENO AND S... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | QUAD AMINO BLEND 150/75/150/75 MG/ML INJECTABLE, all presentations, FOR INTRA... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | GLYCYRRHIZIC ACID 8 MG/ML INJECTABLE, all presentations, FOR INTRAVENO and SQ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | CALCIUM EDTA 200 MG/ML INJECTABLE, all configurations, FOR INTRAVENO AND SQ ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | MAGNESIUM CHLORIDE HEXAHYDRATE 20% INJECTABLE, all presentations, FOR INTRAVE... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | Zinc Sulfate 1 mg/ml INJECTABLE, all configurations, FOR INTRAVENO AND SQ USE... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | OXYTOCIN 10 UNITS/ML, all presentations, FOR INTRAVENO AND SQ USE ONLY, STER... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | TRIAMCINOLONE ACETONIDE 80 MG/ML INJ SUSP, all configurations, FOR INTRAVENO ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | GLUTATHIONE/LIDO 100MG/2%/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | GLUTATHIONE 200 MG/ML (PF) INJ SOLN, all presentations, FOR INTRAVENO and SQ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | ASCORBIC ACID ( non-CORN SOURCE) 500 MG/ML INJECTABLE, all presentations, FOR... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | PARABEN WATER FOR INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | HYDROXOCOBALAMIN (VITAMIN B12A) 1 MG/ML INJECTABLE, all presentations, FOR IN... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
| Jul 26, 2013 | ESTRADIOL CYP/PROG/TEST CYP 0.5/10/10 MG/ML OIL INJ SOLN, all presentations, ... | Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with qu... | Class II | Beacon Hill Medical Pharmacy, P.C. |
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.