PlainRecalls

2021 Recall Year Insight

Federal agencies issued 5,231 product recalls indexed by PlainRecalls in calendar year 2021. That represents about 5.01% of the 104,423 total recalls we track from 1995 through the present, and averages roughly 14.3 recalls per day across the FDA, CPSC, USDA FSIS, and NHTSA combined. Year-level views are the cleanest way to see macro patterns: volume spikes often correlate with new regulatory priorities (e.g., infant-sleep products after 2021, lithium-ion batteries after 2022), supply-chain contamination events, or changes in agency enforcement intensity, while quiet years can reflect either genuine product-safety improvements or reduced agency staffing and reporting lag. With 105 pages at 50 recalls each, browsing this year end-to-end gives a statistically representative sample of what the federal recall pipeline looked like in 2021.

On this page of 50 records, severity classification shows 0 critical, 39 moderate, and 11 lower-severity recalls. The page references 6 distinct recalling firms operating in 2 distinct product categories, with 50 of 50 records disclosing affected-unit counts. Issuing-agency distribution on this slice leans toward FDA Drug (49), FDA Devices (1), which matters because each agency's recall authority, hazard framing, and remedy mechanism differ, an FDA food recall, a CPSC consumer-product recall, and a NHTSA vehicle recall are legally distinct instruments even when the underlying hazard language sounds similar. Reviewing the dominant agency for a given year is one of the fastest ways to understand where federal attention was concentrated.

Year-indexed browsing serves three practical purposes: historical research (tracking how a hazard class evolved over time), consumer action (finding whether a product purchased in 2021 was later recalled), and journalistic or regulatory context (understanding what the enforcement landscape looked like in a given period). Every record on this page links to a full detail view with the hazard, remedy, distribution, and agency-assigned recall number, always use that recall number to verify current status directly with the issuing agency before acting on time-sensitive remedies, because agencies amend, terminate, and expand recalls in the months and years after initial publication. Data on this page reflects federal agency public filings; the agency's live record remains authoritative for legal, medical, or safety decisions. Verify with FDA openFDA, CPSC, USDA FSIS, or NHTSA for the system-of-record on any specific recall. PlainRecalls indexes this archive for research and consumer awareness purposes.

FDA Drug Moderate Nov 3, 2021

TEST CYP 50MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

DEXPANTHENOL 250MG/ML INJ SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)

Ultra Seal Corporation

FDA Drug Low Nov 3, 2021

AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10/240mg), 15-count blister packs, Manufactured by: Ohm Laboratories Inc., 1385 Livingston Avenue, North Brunswick, NJ 08902, NDC 63981-724-15

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Nov 3, 2021

ESTRADIOL VALERATE 5MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

CYCLOSPORINE 2% MCT OIL SUSP, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP 100MG/ML IN ETHYL OLEATE OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

HYDROXYPROG CAPROATE 250MG/ML OIL INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

Lupin Pharmaceuticals Inc.

FDA Drug Moderate Nov 3, 2021

ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41

MACLEODS PHARMA USA, INC

FDA Drug Moderate Nov 3, 2021

TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets/pk, packaged in 10,000 packets, PO# 8967, Mfg. for Tellus/The Provision First Aid Line (Shipping Label)

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

MIT/B12 25/50/50MG/ML 1MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP 200MG/ML MDV ETHYL OLEATE, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

FOLIC ACID 10MG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg (NSAID), Caffeine 65 mg) tablets, 2 Tablets per/package, Packaged in a) 50-count packages/carton, b) 125-count packages/carton, PA-ESF 1414Z, Dist. by: Zee Medical Distributors, LLC Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

FDA Drug Low Nov 3, 2021

AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

TEST CYP 25MG/ML IN ETHYL OLEATE MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

BENZALKONIUM CHLORIDE 0.013% SOLUTION, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

Calcium Chloride, 100 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

METHYLCOBALAMIN 5000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

TEST CYP/PROP/DECA-NAN 125MG/ML (80/10/10) IN SESAME OIL, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

ASCORBIC/GLUTATHIONE 1.25/1.25% OPTH SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate, Extended-Release Tablets, USP 10mg/240mg) , 10-count blister packs, Distributed By Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-5833-15

SUN PHARMACEUTICAL INDUSTRIES INC

FDA Drug Moderate Nov 3, 2021

CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Low Nov 3, 2021

PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)

Ultra Seal Corporation

FDA Drug Moderate Nov 3, 2021

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

ACETYLCYSTEINE 2% OPTH SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Drug Moderate Nov 3, 2021

MIC/B12A 25/50/50MG/ML 1MG/ML MDV, Red Mountain Compounding Rx

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy

FDA Devices Moderate Nov 3, 2021

REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US

W L Gore & Associates, Inc.

Nearby Recall Years

Browse recalls from adjacent calendar years to see how federal enforcement volume has shifted over time.

Compare 2021 with 2020 →

Data Sources

  • Source: FDA openFDA Enforcement API - calendar-year recall filings for food, drugs, and devices
  • Source: USDA FSIS Recalls - calendar-year meat, poultry, and processed egg product recall filings
  • Source: CPSC + NHTSA - consumer product and vehicle recall feeds for 2021

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. Figures cover calendar year 2021 across the FDA, CPSC, USDA FSIS and NHTSA federal recall feeds. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of September 2026.