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
17,899 recalls · Page 310 of 358
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FDA Drug Safety Recall Insight
According to PlainRecalls' agency ranking (distinct recall events, same sort as /agency), FDA Drug Safety sits #3 of 6 (3rd among 6 issuing agencies) with 17,899 notices, about 17.1% of the 104,423-record archive. 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 358 pages of records at 50 recalls per page, this archive represents one of the longest continuous federal enforcement histories accessible to the public.
Record window. FDA Drug Safety records in this archive begin in 2012 , later than the archive's earliest records (1995), so its all-time total spans fewer years than the longest-running agencies in the agency ranking. Counting only 2015 onward, the first year every agency covers, it has 14,526 recalls.
Looking at the 50 records on this page alone, the severity distribution skews toward 0 critical (Class I-equivalent) actions, 50 moderate recalls, and 0 lower-severity notices. Approximately 50 of 50 entries name a specific recalling firm, while 48 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 Jan 29, 2014 to Jan 29, 2014, covering 4 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).
SOTALOL HCL, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093106101.
Aidapak Services, LLC
LACTOBACILLUS ACIDOPHILUS, Tablet, 35 MILLION, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536718101.
Aidapak Services, LLC
AMANTADINE HCL, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781204801.
Aidapak Services, LLC
MINOXIDIL, Tablet, 2.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591564201.
Aidapak Services, LLC
TACROLIMUS, Capsule, 1 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781210301.
Aidapak Services, LLC
sitaGLIPtin PHOSPHATE, Tablet, 50 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006011231.
Aidapak Services, LLC
DUTASTERIDE, Capsule, 0.5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00173071204.
Aidapak Services, LLC
NORTRIPTYLINE HCL, Capsule, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093081001.
Aidapak Services, LLC
ACYCLOVIR, Capsule, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093894001.
Aidapak Services, LLC
AMANTADINE HCL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00832011100.
Aidapak Services, LLC
MULTIVITAMIN/MULTIMINERAL, CHEW Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536344308.
Aidapak Services, LLC
VALSARTAN, Tablet, 80 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078035834.
Aidapak Services, LLC
NeoCitran Extra Strength (acetaminophen 650 mg, pseudoephedrine hydrochloride 60 mg, dextromethorphan hydrobromide 20mg, chlorpheniramine maleate 4 mg, ascorbic acid 5 mg) powder packets, Soothing Lemon flavor, 10-single dose pouches per carton, Novartis Consumer Health Canada Inc., Mississauga, ON, labeled as a) NeoCitran Extra Strength Nighttime Total 7 Symptom Relief (UPC 0 58478 10063 0) and b) NeoCitran Extra Strength Cough, Cold & Flu (UPC 0 58478 47363 5).
Novartis Consumer Health
NIACIN TR, Capsule, 250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904062960.
Aidapak Services, LLC
DOCUSATE SODIUM, Capsule, 250 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536375710.
Aidapak Services, LLC
TOLTERODINE TARTRATE ER, Capsule, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519101.
Aidapak Services, LLC
CALCIUM POLYCARBOPHIL, Tablet, 625 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536430611.
Aidapak Services, LLC
PHENobarbital, Tablet, 64.8 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516721.
Aidapak Services, LLC
NEBIVOLOL HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00456140530.
Aidapak Services, LLC
clonazePAM, Tablet, 0.25 mg (1/2 of 0.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00093083201.
Aidapak Services, LLC
CARBIDOPA/LEVODOPA, Tablet, 25 mg/250 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093029401.
Aidapak Services, LLC
MEXILETINE HCL, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093873901.
Aidapak Services, LLC
Theraflu Severe Cold & Cough powder packets containing Daytime formula (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, and phenylephrine hydrochloride 10 mg), Berry Infused with Menthol & Green Tea flavors and Nighttime formula (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, and phenylephrine hydrochloride 10 mg), Honey Lemon Infused with Chamomile & White Tea flavors; packaged in a) 24-count packets per carton containing 6-count Daytime and 18-count Nighttime packets (UP
Novartis Consumer Health
NIACIN TR, Capsule, 500 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00904063160.
Aidapak Services, LLC
CILOSTAZOL, Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00054004421.
Aidapak Services, LLC
NICOTINE POLACRILEX, LOZENGE, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00135051001.
Aidapak Services, LLC
LEVOTHYROXINE SODIUM, Tablet, 88 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378180701.
Aidapak Services, LLC
GLYCOPYRROLATE, Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603318121.
Aidapak Services, LLC
Theraflu Sugar-Free Nighttime Severe Cold & Cough (acetaminophen 650 mg, diphenhydramine hydrochloride 25 mg, phenylephrine hydrochloride 10 mg) powder packets, Honey Lemon flavor, 6-count packets per carton, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-6318-06, UPC 3 0043-6318-06 0.
Novartis Consumer Health
PANTOPRAZOLE SODIUM DR, Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00008060601.
Aidapak Services, LLC
Theraflu Cold and Flu (acetaminophen 325 mg, phenylephrine hydrochloride 10 mg and pheniramine maleate 20 mg) powder packets, Forest Berries flavor, 10-count packets per box, UPC 4 607045 191760. (Russian product and Former Soviet Union product)
Novartis Consumer Health
LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527134601.
Aidapak Services, LLC
ACYCLOVIR, Tablet, 800 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093894701.
Aidapak Services, LLC
TERAZOSIN HCL, Capsule, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781205301.
Aidapak Services, LLC
MYCOPHENOLIC ACID DR, Tablet, 180 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00078038566.
Aidapak Services, LLC
PROGESTERONE, Capsule, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591396401.
Aidapak Services, LLC
CapsuleTOPRIL, Tablet, 6.25 mg (1/2 of 12.5 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00143117101.
Aidapak Services, LLC
PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516821.
Aidapak Services, LLC
CHLORTHALIDONE, Tablet, 12.5 mg (1/2 of 25 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 00378022201.
Aidapak Services, LLC
CHOLECALCIFEROL, Tablet, 5000 units, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00761017840.
Aidapak Services, LLC
LEVOTHYROXINE SODIUM, Tablet, 112 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074929690.
Aidapak Services, LLC
Propofol Injectible Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, packaged in 5 Units x 20 mL per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Hospira Inc.
NIFEdipine ER, Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591319401.
Aidapak Services, LLC
PHENobarbital, Tablet, 97.2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603516832.
Aidapak Services, LLC
CYANOCOBALAMIN, Tablet, 100 mcg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536354201.
Aidapak Services, LLC
sertraline HCl tablets, 25 mg, 30 Tablets, Rx only, GREENSTONE BRAND --- Distributed by: Greenstone LLC, Peapack, NJ 07977 -- MADE IN INDIA --- NDC 59762-4960-1
Greenstone LLC
Theraflu Daytime Severe Cold & Cough (acetaminophen 650 mg, dextromethorphan hydrobromide 20 mg, phenylephrine hydrochloride 10 mg) powder packets, Berry Infused with Menthol & Green Tea flavors, 6-count packets per carton, , Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0043-6257-06, UPC 3 0043-6257-06 2. Also packaged under foreign label: NeoCitran Extra Strength Daytime Total 7 Symptom Relief (acetaminophen 650 mg, phenylephrine hydrochloride 10 mg, dextro
Novartis Consumer Health
RALTEGRAVIR, Tablet, 400 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00006022761.
Aidapak Services, LLC
PROPRANOLOL HCL, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00603548221.
Aidapak Services, LLC
LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527135001.
Aidapak Services, LLC
Nearby Agencies
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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.
- Source: FDA Drug Safety - verify with the issuing agency: official recall page →
- Source: PlainRecalls Data Index - aggregated from FDA openFDA, CPSC, USDA FSIS, and NHTSA public databases
Every figure on PlainRecalls is rendered directly from official FDA, CPSC, USDA FSIS and NHTSA recall records; no number is typed in by an editor. Recall counts and figures reflect FDA Drug Safety's own published filings, aggregated alongside the other two federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of October 2026.