PlainRecalls
2023 data Federal recall API Linked to agency record

FDA Drug Safety

All recall actions attributed to FDA Drug Safety in our federal database. Each record links back to the agency's official notice so you can verify status, remedy, and amendments before acting.

U.S. Food and Drug Administration — Drug recalls and safety communications

17,683 recalls · Page 80 of 354

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FDA Drug Safety Recall Insight

PlainRecalls tracks 17,683 recall actions attributed to the FDA Drug Safety in our federal recall index. Across the full PlainRecalls database of 100,165 records spanning 1995 through the present, FDA Drug Safety accounts for roughly 17.7% of all indexed recalls. The agency's stated scope — U.S. Food and Drug Administration — Drug recalls and safety communications — determines what classes of products flow through its recall pipeline and how quickly notices reach consumers. With 354 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.

Looking at the 50 records on this page alone, the severity distribution skews toward 1 critical (Class I-equivalent) actions, 49 moderate recalls, and 0 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 49 disclose a unit count — the gap reflects regulatory filing norms where firms disclose lot numbers or distribution channels instead of absolute quantities. This page spans recalls from Mar 2, 2022 to Mar 30, 2022, covering 19 distinct firms. Severity mix is a leading indicator: a page weighted toward critical classifications usually signals an active public-health concern, while lower-severity clusters often represent labeling, undeclared-allergen, or minor design corrections.

Agency-level browsing is useful when a defect pattern crosses categories — for example, a supplier contamination can trigger dozens of downstream recalls that share no obvious product tag but a single issuing agency. Use the pagination below to scan the full archive, or combine this agency filter with category and manufacturer views elsewhere on PlainRecalls to intersect the data. Recall records are sourced directly from FDA Drug Safety's public enforcement feeds and are updated as the agency publishes new notices; the federal record is the authoritative version, and this page aggregates what the agency itself has released. For high-stakes decisions — medical, automotive, or childcare — always click through to the recall detail page and cross-verify the recall number against the agency's current site. Record counts reflect all indexed actions regardless of status (ongoing, terminated, or completed).

Moderate Mar 30, 2022

NAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate …

Olympia Compounding Pharmacy dba Olympia Pharmacy

Moderate Mar 30, 2022

Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-079-11.

Teligent Pharma, Inc.

Moderate Mar 30, 2022

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-0…

Teligent Pharma, Inc.

Moderate Mar 30, 2022

Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence,…

Athenex Pharma Solutions, LLC

Moderate Mar 30, 2022

Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubes, NDC 52565-054-30, Rx Only, …

Teligent Pharma, Inc.

Moderate Mar 30, 2022

Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharm…

Teligent Pharma, Inc.

Moderate Mar 30, 2022

Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-3…

Teligent Pharma, Inc.

Moderate Mar 30, 2022

Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 7051…

Teligent Pharma, Inc.

Moderate Mar 23, 2022

Lorazepam 1 mg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Trimix (Alprostadil/Papaverine/Phentolamine) 10 mcg/20 mg/1 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Methylcobalamin 1 mg/mL Injectable in 1 mL syringes, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Fentanyl 150 mcg/mL Infusion Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTRAlab Laboratories, Inc., NY; Packaged by GSMS, Inc., CA NDC 60429-504-18.

Golden State Medical Supply Inc.

Moderate Mar 23, 2022

Morphine Sulfate 6 mg/mL Infusion in 250 mL bag, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Ketamine 50 mg Infusion (LV 1) Solution in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Hydromorphone HCl 2 mg/mL Infusion 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun Medical Inc., Bethlehem, PA, NDC 0264-7800-20

B. Braun Medical, Inc.

Moderate Mar 23, 2022

Hydromorphone HCl 0.1 mg/mL Infusion in 1000 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Hydromorphone HCl 5 mg/mL Infusion in 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Critical Mar 23, 2022

Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Capsules per carton.

Walmart Stores

Moderate Mar 23, 2022

Vancomycin14 mg/mL Fortified Ophthalmic Solution in 5 mL bottles, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

Trimix (Alprostadil/Papaverine/Phentolamine) 20 mcg/30 mg/0.5 mg Injectable 5 mL vials, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 23, 2022

hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 …

The Harvard Drug Group

Moderate Mar 23, 2022

Hydromorphone HCl 1 mg/mL 250 mL bags, Rx only, Family Pharmacy of Statesville, Inc.

Family Pharmacy of Statesville

Moderate Mar 16, 2022

Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonvi…

Direct Rx

Moderate Mar 16, 2022

Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American…

American Health Packaging

Moderate Mar 16, 2022

PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries …

The Harvard Drug Group

Moderate Mar 16, 2022

Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical Chestnut Ridge, NY 10977 Packaged and Distributed By: Direct Rx Dawsonv…

Direct Rx

Moderate Mar 9, 2022

Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per bottle, NDC: 68788-6381-03, b) 60 tablets per bottle, NDC: 68788-6381-06,…

Preferred Pharmaceuticals, Inc.

Moderate Mar 9, 2022

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleod…

Macleods Pharma Usa Inc

Moderate Mar 9, 2022

HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 473 mL brown bottles with brown colored closures. Distributed by HEB San…

Vi-Jon, Inc.

Moderate Mar 9, 2022

Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Dist. By Aurobindo Pharma USA, Inc. Eas…

Direct Rx

Moderate Mar 9, 2022

Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by: TSM Brands LLC, 540 Equinox Ln, Manalapan, NJ 07726, UPC 868275965734.

Tsm Brands LLC

Moderate Mar 9, 2022

Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 085…

Macleods Pharma Usa Inc

Moderate Mar 9, 2022

All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores located in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tenne…

Dollar Tree Distribution, Inc.

Moderate Mar 9, 2022

70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 ML bottle, Distributed By: TSM Brands LLC, 540 Equinox LN, Manalapan, NJ …

Tsm Brands LLC

Moderate Mar 9, 2022

Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 6…

Morton Grove Pharmaceuticals, Inc.

Moderate Mar 2, 2022

No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 US…

Perrigo Company PLC

Moderate Mar 2, 2022

Acetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: …

Perrigo Company PLC

Moderate Mar 2, 2022

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDO…

Perrigo Company PLC

Moderate Mar 2, 2022

Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle packaged as (a) 8 OZ, UPC 8 19192 02866 8; (b) 16 OZ, UPC 8 19192 02874 3;…

AMS Packaging Inc

Moderate Mar 2, 2022

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNA…

Perrigo Company PLC

Moderate Mar 2, 2022

Children's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc.,…

Perrigo Company PLC

Moderate Mar 2, 2022

Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, …

Perrigo Company PLC

Moderate Mar 2, 2022

Infant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, DISTRIBUTED BY: Wal-Mart Stores, Inc., Bentonville, AR…

Perrigo Company PLC

Moderate Mar 2, 2022

Acetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC:…

Perrigo Company PLC

Moderate Mar 2, 2022

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES L…

Perrigo Company PLC

Moderate Mar 2, 2022

Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, …

Perrigo Company PLC

Moderate Mar 2, 2022

Severe Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION …

Perrigo Company PLC

Moderate Mar 2, 2022

Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07…

RISING PHARMACEUTICALS

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Disclaimer: This information is provided for informational purposes only and does not constitute professional advice. Consult a qualified professional before making decisions based on this data.

Compiled from official public sources by the editorial team.